HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
FDA 510(k) clearance K913757 · decided 1991-10-30
Clearance details
- K-number
- K913757
- Device name
- HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-21
- Decision date
- 1991-10-30
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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