FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
FDA 510(k) clearance K121499 · decided 2012-11-20
Clearance details
- K-number
- K121499
- Device name
- FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-21
- Decision date
- 2012-11-20
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- IZF
- Device class
- 2
- Regulation number
- 892.1740
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Stamford, CT, 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 |
|---|---|---|
| FULL FIELD DIGITAL MAMMOGRAPHY (P050014/S002) | Fujifilm Medical System U.S.A., Inc. | 2009-08-11 |
| FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (P050014/S001) | Fujifilm Medical System U.S.A., Inc. | 2009-01-09 |
| FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS) (P050014) | Fujifilm Medical System U.S.A., Inc. | 2006-07-10 |