FS IV MINI C-ARM SYSTEM
FDA 510(k) clearance K974058 · decided 1998-01-12
Clearance details
- K-number
- K974058
- Device name
- FS IV MINI C-ARM SYSTEM
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-27
- Decision date
- 1998-01-12
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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No recalls on record reference this clearance.
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