SnapShot Freeze 2 5963072

GUDID 00195278865335

SnapShot Freeze Medical Device

GE MEDICAL SYSTEMS, INC.

CT system application software
Primary Device ID00195278865335
NIH Device Record Key0e09a3a8-4e98-4d31-afc8-8dea9cf42520
Commercial Distribution StatusIn Commercial Distribution
Brand NameSnapShot Freeze 2
Version Model Number1.1
Catalog Number5963072
Company DUNS809785715
Company NameGE MEDICAL SYSTEMS, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278865335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-21
Device Publish Date2024-10-11

Devices Manufactured by GE MEDICAL SYSTEMS, INC.

00195278560384 - Auto Segmentation2024-11-13 MD Auto Segmentation for Smart Subscription
00195278865335 - SnapShot Freeze 22024-10-21SnapShot Freeze Medical Device
00195278865335 - SnapShot Freeze 22024-10-21 SnapShot Freeze Medical Device
00195278804990 - Revolution2024-09-23 Revolution UPG3 - Designated System Medical Device
00195278901439 - Omni2024-09-23 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY - WSO
00195278454218 - Omni2024-08-15 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY
00195278840226 - Discovery2024-07-12 XR656HD UDI Label
00195278840233 - Optima2024-07-12 XR646HD UDI Label
00195278792822 - Omni2024-04-19 OMNI GANTRY ELECTRONICS ASSY, MEA

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