Identity
- Trade Name
- Discovery FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Model / Reference
- IQ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682103107 FDA UDI
- 510(k) Number
- K141477 FDA UDI
- FDA Product Code
- JAK FDA UDIKPS FDA UDI
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI892.1200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Full-body CT systemPET system
Discovery by Ge Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
- Discovery — GE MEDICAL SYSTEMS, INC. · Class II
Cleared under the same submission
K141477 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ge Medical Systems, Inc.
Sources (1)
- FDA UDI 14e294d5-81df-4177-9098-f6f663da18f9 33 fields · synced Jun 8, 2026