FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
FDA 510(k) clearance K051025 · decided 2005-05-13
Clearance details
- K-number
- K051025
- Device name
- FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-22
- Decision date
- 2005-05-13
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |