MAMMOSITE CAVITY EVALUATION DEVICE
FDA 510(k) clearance K081179 · decided 2008-05-09
Clearance details
- K-number
- K081179
- Device name
- MAMMOSITE CAVITY EVALUATION DEVICE
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-25
- Decision date
- 2008-05-09
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Malborough, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| 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 |