Identity
- Trade Name
- Centricity FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Model / Reference
- CPACS 7.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682145558 FDA UDI
- 510(k) Number
- K110875 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological PACS software
Centricity by GE Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiological PACS software.
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- QuantX — Qlarity Imaging · Class II
- interWORKS — Avreo, Inc. · Class I
- NovaPACS — Novarad Corporation · Class II
- OrthoNext™ Platform System Software — Orthofix, Inc. · Class II
Cleared under the same submission
K110875 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 Healthcare
Sources (1)
- FDA UDI 8c829beb-a11c-4af5-8507-1517bbf933a5 34 fields · synced Jun 6, 2026