Identity
- Trade Name
- FDR-2000BPY FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the image obtained from an exposure and supports the positioning of the needle using the coordinates. FDA UDI
- Model / Reference
- POSITIONER KIT BPY-L HA USA E FDA UDI
- Description
- The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the image obtained from an exposure and supports the positioning of the needle using the coordinates. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410336047 FDA UDI
- FDA Product Code
- IZH FDA UDIMUE FDA UDI
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1710 FDA UDI892.1715 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
Yes
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
Fdr-2000bpy by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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K191495 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
- FUJIFILM Corporation
Sources (1)
- FDA UDI 4eddbd8b-10e5-4468-83df-d1097d1d9e68 36 fields · synced Jun 8, 2026