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The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA.
ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.
CANDELIS, INC.
IG-UHP-R1H-R-SAAS
In Commercial Distribution
- B193IGUHPR1HRSAAS0 ()
- Radiological PACS software
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA.
ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.
CANDELIS, INC.
IG-UHP-R1H-R
In Commercial Distribution
- B193IGUHPR1HR0 ()
- Radiological PACS software
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA.
ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.
CANDELIS, INC.
IG-UHP-R1B-DR
In Commercial Distribution
- B193IGUHPR1BDR0 ()
- Radiological PACS software
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA.
ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.
CANDELIS, INC.
IG-UHP-R1B
In Commercial Distribution
- B193IGUHPR1B0 ()
- Radiological PACS software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2
diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStar is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.
BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v6.2
In Commercial Distribution
- B553BLUESTAR620 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2
diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStar is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.
BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v6.1
Not in Commercial Distribution
- B553BLUESTAR610 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2
diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.
BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
Caution: Federal law restricts this device to sale by or on the order of a physician.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v6.2
In Commercial Distribution
- B553BLUESTARRX620 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2
diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.
BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
Caution: Federal law restricts this device to sale by or on the order of a physician.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v6.1
Not in Commercial Distribution
- B553BLUESTARRX610 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2
diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.
BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
Caution: Federal law restricts this device to sale by or on the order of a physician.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v5.7
Not in Commercial Distribution
- B553BLUESTARRX570 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2
diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.
BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
Caution: Federal law restricts this device to sale by or on the order of a physician.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v5.6
Not in Commercial Distribution
- B553BLUESTARRX560 ()
- Home pharmaceutical management support software