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The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.6.0
In Commercial Distribution
- 00850012642053 ()
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.5.0
In Commercial Distribution
- 00850012642046 ()
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.4.0
In Commercial Distribution
- 00850012642039 ()
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.3.0
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
V0.1.4
In Commercial Distribution
- 00850012642015 ()
- MRI image interpretive software
AI SaMD for prostate cancer.
Avenda Health, Inc.
V0.1.4
In Commercial Distribution
- 00850012642008 ()
- MRI image interpretive software
PROG-004 Kit (US)
Avertix Medical Inc.
0217-2100-004#P18
In Commercial Distribution
- 00850012625162 ()
0217-2100-004#P18
- Implantable cardiac device management application software
EXD-001 Battery, Single
Avertix Medical Inc.
0203-2100-006
In Commercial Distribution
- 00850012625155 ()
0203-2100-006
- Primary battery
PROG-003 Carrying Case
Avertix Medical Inc.
0204-2100-079#P10
In Commercial Distribution
- 00850012625148 ()
0204-2100-079#P10
- Implantable cardiac device management application software
PROG-003 Application User's Manual CD
Avertix Medical Inc.
0204-2100-073#P16
In Commercial Distribution
- 00850012625131 ()
0204-2100-073#P16
- Implantable cardiac device management application software
PROG-003 USB Flash Drive
Avertix Medical Inc.
0204-2100-077#P10
In Commercial Distribution
- 00850012625124 ()
0204-2100-077#P10
- Implantable cardiac device management application software
PROG-003 External Power Accessories Kit (US)
Avertix Medical Inc.
0204-2100-093#P10
In Commercial Distribution
- 00850012625100 ()
0204-2100-093#P10
- Implantable cardiac device management application software
PROG-003 Serial Cable (10 foot)
Avertix Medical Inc.
0204-2100-112
In Commercial Distribution
- 00850012625094 ()
0204-2100-112
- Implantable cardiac device management application software
PROG-003 Serial Cable (6 foot)
Avertix Medical Inc.
0204-2100-085#P10
In Commercial Distribution
- 00850012625087 ()
0204-2100-085#P10
- Implantable cardiac device management application software
PROG-003 Wand
Avertix Medical Inc.
0204-2100-067#P15
In Commercial Distribution
- 00850012625070 ()
0204-2100-067#P15
- Implantable cardiac monitor programmer/transmitter/alarm
PROG-003 Kit (US)
Avertix Medical Inc.
0204-2100-075#P16
In Commercial Distribution
- 00850012625063 ()
0204-2100-075#P16
- Implantable cardiac device management application software
EXD Lanyard
Avertix Medical Inc.
0203-2100-003
In Commercial Distribution
- 00850012625056 ()
0203-2100-003
- Implantable cardiac monitor programmer/transmitter/alarm
EXD Carrying Case
Avertix Medical Inc.
0203-2100-004
In Commercial Distribution
- 00850012625049 ()
0203-2100-004
- Implantable cardiac monitor programmer/transmitter/alarm
EXD-001 Kit (Latin-American Spanish)
Avertix Medical Inc.
0203-2100-002-C4#P16
In Commercial Distribution
- 00850012625032 ()
0203-2100-002-C4#P16
- Implantable cardiac monitor programmer/transmitter/alarm
EXD-001 Kit
Avertix Medical Inc.
0203-2100-002#P16
In Commercial Distribution
- 00850012625025 ()
0203-2100-002#P16
- Implantable cardiac monitor programmer/transmitter/alarm
Hex Torque Wrench (Separate, in Sterile Pack)
Avertix Medical Inc.
2100-001
In Commercial Distribution
- 00850012625018 ()
- 10850012625015 ()
2100-001
- Surgical torque wrench, single-use
IMD AMSG3-E Kit
Avertix Medical Inc.
0212-2100-001#P16
In Commercial Distribution
- 00850012625001 ()
0212-2100-001#P16
- Implantable cardiac monitor
No Description
M3 Global Enterprises, LLC
Royal Strawberry Condoms Box of 12
Not in Commercial Distribution
- 00850012584445 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Ultra Thin Natural XL Condoms Box of 10
In Commercial Distribution
- 00850012584179 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Ultra Thin Natural XL Condoms Box of 20
In Commercial Distribution
- 00850012584162 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Chocolate Condoms Box of 20
In Commercial Distribution
- 00850012584155 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Chocolate Condoms Box of 3
In Commercial Distribution
- 00850012584148 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Chocolate Condoms Box of 10
In Commercial Distribution
- 00850012584131 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Strawberry Condoms Box of 20
In Commercial Distribution
- 00850012584124 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Strawberry Condoms Box of 3
In Commercial Distribution
- 00850012584117 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Strawberry Condoms Box of 10
In Commercial Distribution
- 00850012584100 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Ultra Thin Natural Condoms Box of 10
In Commercial Distribution
- 00850012584032 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Ultra Thin Natural Condoms Box of 20
In Commercial Distribution
- 00850012584025 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Natural Condoms Box of 10
In Commercial Distribution
- 00850012584018 ()
- Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Natural Condoms Box of 3
In Commercial Distribution
- 00850012584001 ()
- Basic male condom, Hevea-latex
LEG GARMENT, DAYSPRING, LONG, RIGHT
Koya Medical, Inc.
F-0040-08
Not in Commercial Distribution
- 00850012532798 ()
- Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, LONG, LEFT
Koya Medical, Inc.
F-0040-07
Not in Commercial Distribution
- 00850012532781 ()
- Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, MEDIUM, RIGHT
Koya Medical, Inc.
F-0040-06
Not in Commercial Distribution
- 00850012532774 ()
- Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, MEDIUM, LEFT
Koya Medical, Inc.
F-0040-05
Not in Commercial Distribution
- 00850012532767 ()
- Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, SHORT, RIGHT
Koya Medical, Inc.
F-0040-04
Not in Commercial Distribution
- 00850012532750 ()
- Wearable sequential venous compression system