FDA.reportPublic FDA data

SnapShot Freeze

Primary DI
00198953050996
Brand
SnapShot Freeze
Company
GE Medical Systems, L.L.C.
Model
see code part
Catalog number
5987386
Device description
SnapShot Freeze Medical Device
Published
2026-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183161000SnapShot Freeze 2Ge Medical Systems, LLC2019-02-13JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953050996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953050996001989530509961989530509960198953050996

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image interpretive software sharing portalAn application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility.

Regulatory Flags#

DUNS number
144879404
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953007716NASIGNA Bolt2026-10-07
00198953085950PhotonovaSpectra5590000-502026-05-11
00195278789365Critical Care Suite2.158331262023-10-19
00195278460271RevolutionApex Elite5590000-232022-12-16
00195278471277Revolution CTES with Apex edition5826588-X2022-12-16
00195278502179RevolutionApex Plus5590000-252022-12-16
00195278486813NASIGNA Hero2022-02-11
00195278472083NA6265300-202021-12-31
00195278098603DiscoveryMI2020-10-20
00195278023643NASIGNA Architect2020-07-20
00198953255315NA9265300-32026-07-08
00840682138796Revolution160mm Detector Upgrade2018-01-11
00198953081839NA6265300-602026-04-02
00198953081877NA6265300-622026-04-02
00840682120784Flashpad HD25302017-07-28
00840682120807Flashpad HD35432017-07-28
00840682103053DiscoveryPETCT 6102016-08-01
00840682143974O560 to 610 Upgrade5607000-22018-12-05
00840682145749OptimaXR240amx HD Upgrade Gen22019-07-15
10840682142875Discovery PET CT690 VCT Boost Upgrade2018-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760305400246DUAL SIDED NEEDLE GUIDEQUANTUM SURGICALJAK2026-10-19
03760305400277PATIENT REFERENCE 2.0QUANTUM SURGICALJAK2026-10-19
05745000308385Cercare Medical NeurosuiteCercare Medical A/SLLZ2026-10-17
05745000308392Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SLLZ2026-10-16
75401622502301Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-16
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
19356870000045CAC4DMEDICAL LIMITEDJAK2026-10-13
19356870000090LDA4DMEDICAL LIMITEDJAK2026-10-13
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
00860016243804C-beamPulmera, Inc.JAK2026-10-10
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
00884838120433SmartCTPhilips Medical Systems Nederland B.V.JAK2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
00860015781925Bunkerhill Contrast AVCBunkerhill Health Inc.JAK2026-09-16
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00884838129559CT Areta RT/Rembra RT UpgradesPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-08-21