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SW D00U003 SS AZURE ASTRA
MEDTRONIC, INC.
D00U003
In Commercial Distribution
- 00763000002039 ()
- Implantable cardiac device management application software
SW CLN CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN
In Commercial Distribution
- 00763000017347 ()
- Implantable cardiac device management application software
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
lnclinometer wireless
In Commercial Distribution
- EPTWT430360 ()
T43036
- Bone densitometry ultrasound phantom, test object
Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s):
- S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer)
- S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools
- I1 = Restin-ECG Measurement
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1
In Commercial Distribution
- 07290110252793 ()
HASP-SW-K-S2I1-01
- Cardiovascular risk evaluation interpretive software
- Cardiopulmonary stress exercise monitoring system computer
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application.
The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution
- G618000010 ()
- Ultrasound imaging system operation software
- Hand-held ultrasound imaging system, body-surface
- Ultrasound imaging system operator console
Galilei G6 Lens Professional
SIS AG, Surgical Instrument Systems
G6
In Commercial Distribution
- 07640167751242 ()
410.030.007
- Optical low coherence reflectometry (OLCR) biometer
- Eye anterior segment analyser
- Corneal topography system application software
iFusion 80 with 12 MP Camera
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006766 ()
700-54542-001
- Ophthalmic spectral-domain optical coherence tomography system
- Ophthalmic fundus camera
iVue NR for iFusion USCFG 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006650 ()
700-49003-005
- Ophthalmic spectral-domain optical coherence tomography system
- Ophthalmic fundus camera
iVue NR for iFusion 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006643 ()
700-49002-005
- Ophthalmic spectral-domain optical coherence tomography system
- Ophthalmic fundus camera
iVue NR for iFusion USCFG 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006636 ()
700-49001-005
- Ophthalmic spectral-domain optical coherence tomography system
- Ophthalmic fundus camera
iVue NR for iFusion 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006629 ()
700-49000-005
- Ophthalmic spectral-domain optical coherence tomography system
- Ophthalmic fundus camera
iVue NR for iFusion USCFG System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006247 ()
700-48371-003
- Ophthalmic fundus camera
- Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006230 ()
700-48363-003
- Ophthalmic fundus camera
- Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion USCFG 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006209 ()
700-49003-004
- Ophthalmic fundus camera
- Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006193 ()
700-49002-004
- Ophthalmic fundus camera
- Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006179 ()
700-49000-004
- Ophthalmic fundus camera
- Ophthalmic spectral-domain optical coherence tomography system
The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.
TRACEY TECHNOLOGIES, CORPORATION
iTrace
In Commercial Distribution
- 00860479001706 ()
Z2000
- Corneal topography system
- Automated ophthalmic refractometer
iVue NR for iFusion USCFG System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006308 ()
700-48586-003
- Ophthalmic fundus camera
- Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006292 ()
700-48585-003
- Ophthalmic fundus camera
- Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion USCFG 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution
- 00858848006186 ()
700-49001-004
- Ophthalmic fundus camera
- Ophthalmic spectral-domain optical coherence tomography system
Pathway® CTS 1500
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS1500
In Commercial Distribution
- 00852423006028 ()
CTS1500
- Psychophysiological biofeedback system
- Perineal orifice incontinence-control electrical stimulation system, professional
Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution
- 00852423006011 ()
CTS2000
- Psychophysiological biofeedback system
- Perineal orifice incontinence-control electrical stimulation system, professional
No Description
Brainlab AG
18097
In Commercial Distribution
- 04056481004958 ()
- 04056481006525 ()
- 04056481004965 ()
18097
- Robotic surgical navigation system
- Intracranial catheter navigation transmitter stylet
The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions.
These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.
The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc.
It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.
Carl Zeiss Meditec AG
CIRRUS photo 800
In Commercial Distribution
- 04049471096026 ()
- Weight: 33 Kilogram
- Total height (including head rest) 1390 mm (plus 300 mm lift)
- Footprint of table-top unit 469 mm x 466 mm (including lateral cable covers)
- Utility space of instrument table (W x D) 1060 mm x 420 mm
- Ophthalmic spectral-domain optical coherence tomography system
- Ophthalmic fundus camera
The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions.
These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.
The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc.
It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.
Carl Zeiss Meditec AG
CIRRUS photo 600
In Commercial Distribution
- 04049471096019 ()
- Weight: 33 Kilogram
- Total height (including head rest) 1390 mm (plus 300 mm lift)
- Footprint of table-top unit 469 mm x 466 mm (including lateral cable covers)
- Utility space of instrument table (W x D) 1060 mm x 420 mm
- Ophthalmic spectral-domain optical coherence tomography system
- Ophthalmic fundus camera
The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of a mydriatic agent to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.
CENTERVUE SPA
RETIA 2
In Commercial Distribution
- 08053677040086 ()
AINEUME002
- Ophthalmic fundus camera
- Scanning-laser retinal imaging system
No Description
LUNEAU TECHNOLOGY OPERATIONS
VISUREF 1000
In Commercial Distribution
- 03664188000589 ()
- Multiple ocular dimension meter
- Ophthalmic fundus camera
No Description
LUNEAU TECHNOLOGY OPERATIONS
DNEye Scanner 3
In Commercial Distribution
- 03664188000404 ()
- Multiple ocular dimension meter
- Ophthalmic fundus camera
Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
WELLOVATE, LLC
1
In Commercial Distribution
- G741WHREHABV10 ()
- Biomechanical function analysis/interactive rehabilitation system
- Biomechanical function analysis/rehabilitation software
A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The N-140 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. N-140 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
N-140 (Rotate)
In Commercial Distribution
- 07290016986099 ()
- Biomechanical function analysis/interactive rehabilitation system
- Biomechanical function analysis/rehabilitation software
A software-only medical device intended for upper extremity and full body rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The MT-220 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MT-220 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MT-220 (Balloon Blast)
In Commercial Distribution
- 07290016986082 ()
- Biomechanical function analysis/interactive rehabilitation system
- Biomechanical function analysis/rehabilitation software
A software-only medical device intended for motor-cognitive rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of motor-cognitive exercises according to their treating medical practitioner's guidelines. The MC-320 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MC-320 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MC-320 (Color Match)
In Commercial Distribution
- 07290016986075 ()
- Biomechanical function analysis/interactive rehabilitation system
- Biomechanical function analysis/rehabilitation software
No Description
MAICO Diagnostics GmbH
MA 42
Not in Commercial Distribution
- 04260176120902 ()
- Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 27
In Commercial Distribution
- 04260176120865 ()
- Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 1
In Commercial Distribution
- 04260176120858 ()
- Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 41
Not in Commercial Distribution
- 04260176120704 ()
- Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 25
In Commercial Distribution
- 04260176120377 ()
- Tone audiometer
Senti Desktop Flex Screening Set
Content:
1. Case AN100503
2. Inlay Sentiero AN100385
3. Senti Desktop Flex device AN100433
4. Headphone DD-45 AN100306
5. FW Labelprinter AN100414
6. FW Pure Tone Audiometer Class 4 Advanced AN100653
7. Power supply AN100524 + AN100525-USA or AN101360 + 101251-USA optionally
8. USB data cable AN100418
PATH medical GmbH
100470-SC
In Commercial Distribution
- 04260223145285 ()
- Tone audiometer
Senti Audiometry (Class 4 Advanced) Set Content:
1. Case AN100503
2. Inlay Sentiero AN100677
3. Senti device with touchscreen AN100097
4. FW Labelprinter AN100414
5. Pure Tone Audiometer Class 4A AN100653
6. Headphone HDA-280 AN100117
7. Power supply AN100083
8. USB data cable AN100089
PATH medical GmbH
100330
Not in Commercial Distribution
- 04260223143151 ()
- Tone audiometer
Senti Desktop Flex Basic Set Content:
1. Case AN100503
2. Inlay Sentiero AN100385
3. Senti Desktop Flex device AN100433
4. Headphone DD-45 AN100306
5. FW Labelprinter AN100414
6. FW Pure Tone Audiometer Class 3 AN100114
7. Bone Conductor B81 AN100888 or B71W AN100344 optionally
8. Patient response button AN100171
9. Power supply AN100524 + AN100525-USA or AN101360 + AN101251-USA optionally
10. USB data cable AN100418
PATH medical GmbH
100470
In Commercial Distribution
- 04260223142987 ()
- Tone audiometer