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SnapShot Freeze 2
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 5807631Model 2Ref 5987386 Model SnapShot Freeze
Identity
- Trade Name
- SnapShot Freeze 2 EUDAMEDSnapShot Freeze EUDAMEDFDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- SnapShot Freeze EUDAMED
- Model / Reference
- 2 EUDAMEDFDA UDI5807631 EUDAMEDSnapShot Freeze EUDAMED5987386 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682142601 EUDAMEDFDA UDI00198953050996 EUDAMED
- Basic UDI-DI
- B-00840682142601 EUDAMED08406821BUG005937S EUDAMED
- Direct Marketing DI
- 00198953050996 EUDAMED
- 510(k) Number
- K120910 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Special Device Type
- -1192 EUDAMEDSoftware EUDAMED
- Market of Registration
- France EUDAMEDBelgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
SnapShot Freeze 2 by GE Medical Systems, LLC — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840682142601 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K183161 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00840682142601 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
- EUDAMED SRN
- US-MF-000018315
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (4)
- EUDAMED ad13f6fb-4f1b-4cc7-b58d-fd89959db4d5 61 fields · synced Aug 1, 2026
- FDA UDI 90b0fc4e-ee8e-4f4c-bb00-3a68ad62f68f 33 fields · synced May 29, 2026
- EUDAMED 40f201c1-c1af-4e97-aada-8d23e3a37449 61 fields · synced Jul 28, 2026
- FDA 510(k) K183161 1 fields · synced May 18, 2026