Identity
- Trade Name
- Lateral Approach Kit FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- When the Lateral Approach Kit is installed onto the FDR-2000BPY positioner, it determines and retains the position of needle insertion in the vertical direction (90 degree, -90 degree) in relation to the direction of breast compression. FDA UDI
- Model / Reference
- LATERAL BIOPSY KIT HA USA E FDA UDI
- Description
- When the Lateral Approach Kit is installed onto the FDR-2000BPY positioner, it determines and retains the position of needle insertion in the vertical direction (90 degree, -90 degree) in relation to the direction of breast compression. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410327359 FDA UDI
- 510(k) Number
- K133972 FDA UDI
- FDA Product Code
- MUE FDA UDI
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1715 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
No
FDA UDI
Category: Stationary mammographic x-ray system, digital
Lateral Approach Kit by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary mammographic x-ray system, digital.
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia® Dimensions® — Hologic, Inc. · Class II
- Senographe Pristina — GE MEDICAL SYSTEMS, INC. · Class II
- 3Dimensions — Hologic, Inc. · Class III
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia® Dimensions® — Hologic, Inc. · Class II
- GIOTTO IMAGE — IMS GIOTTO SPA · Class II
Cleared under the same submission
K133972 also covers:
- 18x24 Compression plate (High) — FUJIFILM Corporation
- 18x24 Compression plate (Low) — FUJIFILM Corporation
- 18x24 Spot compression plate — FUJIFILM Corporation
- 18x24 comfort paddle (FS Small) — FUJIFILM Corporation
- 18x24 compression plate (Small) — FUJIFILM Corporation
- 18x24L comfort paddle (FS) — FUJIFILM Corporation
- 18x24L compression plate (Flex) — FUJIFILM Corporation
- 1Shot Phantom M Plus 24x30 — FUJIFILM Corporation
- 24x30 Compression plate (High) — FUJIFILM Corporation
- 24x30 Compression plate (Low) — FUJIFILM Corporation
- 24x30 compression plate (Shift Small) — FUJIFILM Corporation
- 24x30 compression plate (Shift) — FUJIFILM Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI 069aef09-ee96-40de-bed5-c4947dd79849 35 fields · synced May 31, 2026