CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
FDA 510(k) clearance K123873 · decided 2013-01-29
Clearance details
- K-number
- K123873
- Device name
- CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-17
- Decision date
- 2013-01-29
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- MUE
- Device class
- 2
- Regulation number
- 892.1715
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NovaSure Model 10 RF Controller (P010013/S094) | Hologic, Inc. | 2025-12-17 |
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| Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System (P920048/S027) | Hologic, Inc. | 2024-12-06 |
| TLiIQ QCette (P920048/S026) | Hologic, Inc. | 2024-10-23 |
| Aptima CMV Quant Assay (P210029/S002) | Hologic, Inc. | 2024-10-23 |
| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |