VMA Image Acquisition Software

GUDID 00868579000230

VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)

ORTHO KINEMATICS, INC.

Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software
Primary Device ID00868579000230
NIH Device Record Keyb6d3e4bb-081f-4958-8107-6072c66e9ba2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVMA Image Acquisition Software
Version Model Number3
Company DUNS932053221
Company NameORTHO KINEMATICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM
Phone5123345490
EmailINFO@ORTHOKINEMATICS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100868579000230 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-23
Device Publish Date2017-12-12

Devices Manufactured by ORTHO KINEMATICS, INC.

00868579000216 - VMA DataLink Software2019-05-23
00868579000223 - VMA DataLink Software2019-05-23 VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
00868579000230 - VMA Image Acquisition Software2019-05-23VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
00868579000230 - VMA Image Acquisition Software2019-05-23 VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
00868579000261 - Profile-ESP Bolster2019-03-11 The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA S
00868579000278 - Profile-ESP Radiographic marker2019-03-11 The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate
00868579000209 - VMA2019-02-21
00868579000247 - VMA Motion Normalizer2019-02-21 VMA Motion Normalizer (Console, Table, and Upright assemblies)
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