Identity
- Trade Name
- Senographe Pristina FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Model / Reference
- EKB1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682118460 FDA UDI
- 510(k) Number
- K162268 FDA UDI
- FDA Product Code
- MUE FDA UDIIWX FDA UDIITY FDA UDIFMQ FDA UDIIZO FDA UDIIXJ FDA UDIIZW FDA UDI
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1715 FDA UDI892.6500 FDA UDI892.1760 FDA UDI880.6760 FDA UDI892.1700 FDA UDI892.1910 FDA UDI892.1610 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: Stationary mammographic x-ray system, digital
Senographe Pristina by Ge Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Stationary mammographic x-ray system, digital.
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- 3Dimensions — Hologic, Inc. · Class III
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia® Dimensions® — Hologic, Inc. · Class II
Cleared under the same submission
K162268 also covers:
- MagStand 1.5 — GE MEDICAL SYSTEMS, INC.
- MagStand 1.8 — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
- Pristina Paddle — GE MEDICAL SYSTEMS, INC.
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 09732d87-2cb8-4447-aea1-22adde39ea7e 34 fields · synced May 30, 2026