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Discovery IQ
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref PCM-PET0008AModel Discovery IQ
Identity
- Trade Name
- Discovery IQ EUDAMEDDiscovery FDA UDI
- Generic Name
- PET system FDA UDI
- Device Name
- Discovery IQ EUDAMED
- Model / Reference
- Discovery IQ EUDAMEDPCM-PET0008A EUDAMEDIQ 2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682125703 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00414HB EUDAMED
- 510(k) Number
- K141477 FDA UDI
- FDA Product Code
- KPS FDA UDI
- EMDN Code
- Z11020301 CT/PET SYSTEMS EUDAMED
- GMDN Term
- PET system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Market of Registration
- Czechia 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
Yes
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
Yes
FDA UDI
Discovery IQ by GE Medical Systems, LLC — Class IIb — 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 | K141477 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00414HB | Class IIb | 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 (3)
- EUDAMED 318eadf8-6420-4394-8dd6-159e4a469e5b 61 fields · synced Jul 28, 2026
- FDA UDI 5f37ce9d-04f9-4a63-9a95-949863a46606 33 fields · synced May 29, 2026
- FDA 510(k) K141477 1 fields · synced May 18, 2026