Identity
- Trade Name
- Pristina Paddle FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- SLIDING 19X23 PADDLE - labelled FDA UDI
- Model / Reference
- 19X23SLD FDA UDI
- Description
- SLIDING 19X23 PADDLE - labelled FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278527950 FDA UDI
- 510(k) Number
- K162268 FDA UDI
- FDA Product Code
- FMQ FDA UDI
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary mammographic x-ray system, digital
Pristina Paddle is a stationary assembly of devices designed to generate high-quality x-ray images of the breast using digital techniques, making it an ideal solution for breast cancer screening and biopsy procedures. The device compresses the breast during imaging, creating two-dimensional (2-D) or three-dimensional (3-D) x-ray images that can be processed into detailed models of blood and lymphatic vessels.
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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
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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.
- Senographe Pristina — GE MEDICAL SYSTEMS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ge Medical Systems, Inc.
Sources (1)
- FDA UDI ad2235f1-dd5a-4f14-bc2f-3834263da227 35 fields · synced Jul 6, 2026