← Back to catalogue
Spectral Bone Marrow
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 5973667Model Spectral Bone MarrowRef 5929650
Identity
- Trade Name
- Spectral Bone Marrow EUDAMEDFDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- Spectral Bone Marrow EUDAMEDSpectral Bone Marrow MD Application Container for Smart Subscription FDA UDI
- Model / Reference
- Spectral Bone Marrow EUDAMED5973667 EUDAMED5929650 EUDAMED1.0 FDA UDI
- Description
- Spectral Bone Marrow MD Application Container for Smart Subscription FDA UDI
Identifiers
- Catalog Number
- 5929650 FDA UDI
- Primary DI / UDI-DI
- 00195278932358 EUDAMED00195278630377 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00412H7 EUDAMED
- Direct Marketing DI
- 00195278932358 EUDAMED00195278630377 EUDAMED
- 510(k) Number
- K223514 FDA UDI
- FDA Product Code
- QIH FDA UDIJAK 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
- 892.2050 FDA UDI892.1750 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium EUDAMEDFrance 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Spectral Bone Marrow by GE Medical Systems, LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223514 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00412H7 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE Medical Systems, LLC
- EUDAMED SRN
- US-MF-000018315
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (4)
- EUDAMED cb487138-1bfc-4ab5-9f79-2cdc07f55b96 61 fields · synced Jul 16, 2026
- EUDAMED 6d02a3ed-e8cf-4ff0-8a03-120e561170fc 61 fields · synced May 18, 2026
- FDA UDI 6881507b-9eea-4b0e-9685-6586b7f763f2 35 fields · synced May 30, 2026
- FDA 510(k) K223514 1 fields · synced May 18, 2026