Identity
- Trade Name
- Affirm Prone Biopsy System FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- AFFIRM PRONE BIOPSY ACQUISITION WORKSTATION FDA UDI
- Model / Reference
- ASY-08832 FDA UDI
- Description
- AFFIRM PRONE BIOPSY ACQUISITION WORKSTATION FDA UDI
Identifiers
- Catalog Number
- ASY-08832 FDA UDI
- Primary DI / UDI-DI
- 15420045506534 FDA UDI
- 510(k) Number
- K153486 FDA UDI
- FDA Product Code
- IZH FDA UDI
- GMDN Term
- Mammographic stereotactic biopsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1710 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: Mammographic stereotactic biopsy system
Affirm Prone Biopsy System by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mammographic stereotactic biopsy system.
- BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
- ENCOR® — SENORX, INC. · Class II
- Mammotome — Devicor Medical Products, Inc. · Class II
- ENCOR® — SENORX, INC. · Class II
- EleVation™ — Bard Peripheral Vascular · Class II
- Mammotome elite — Devicor Medical Products, Inc. · Class II
- Mammotome revolve — Devicor Medical Products, Inc. · Class II
- Mammotome MR — Devicor Medical Products, Inc. · Class II
Cleared under the same submission
K153486 also covers:
- Affirm Prone Biopsy System — Hologic, Inc.
- Affirm Prone Biopsy System — Hologic, Inc.
- Affirm Prone Biopsy System — Hologic, Inc.
- Affirm Prone Biopsy System — Hologic, Inc.
- Affirm Prone Biopsy System — Hologic, Inc.
- Affirm Prone Biopsy System — Hologic, Inc.
- Affirm Prone Biopsy System — Hologic, Inc.
- Affirm Prone Biopsy System — Hologic, Inc.
- Affirm Prone Biopsy System — Hologic, Inc.
- Affirm Prone Biopsy System — Hologic, 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
- Hologic, Inc.
Sources (1)
- FDA UDI a1d9cc7d-cd5f-47f4-a9fd-7a43c37b69ae 37 fields · synced May 30, 2026