FULL FIELD DIGITAL MAMMOGRAPHY
FDA premarket approval P050014/S002 · decided 2009-08-11
Approval details
- PMA number
- P050014
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FULL FIELD DIGITAL MAMMOGRAPHY
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Date received
- 2009-07-15
- Decision date
- 2009-08-11
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Stamford, CT
- Statement
- APPROVAL FOR: 1) CHANGES IN THE CNR WEEKLY CHECK - QC TECHNOLOGIST; 2) CHANGE TO THE MONITOR QC - MEDICAL PHYSICIST TEST LUMINANCE RESPONSE TEST; 3) NEW TERMINOLOGY REGARDING USE OF THE TERM -ACQUISITION WORKSTATION; AND 4) TRADE NAME CHANGE TO ASPIRE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Processor VP-7000, Light Source BL-7000 (K163675) | Fujifilm Medical System U.S.A., Inc. | 2017-04-25 |
| Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 (K153206) | Fujifilm Medical System U.S.A., Inc. | 2016-03-03 |
| Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (K151474) | Fujifilm Medical System U.S.A., Inc. | 2016-02-18 |
| FDR D-EVO GL Flat Panel Detector System (K152138) | Fujifilm Medical System U.S.A., Inc. | 2015-11-05 |
| EPX-4440HD and EPX-4400HD with FICE (K150221) | Fujifilm Medical System U.S.A., Inc. | 2015-10-01 |
| EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (K142629) | Fujifilm Medical System U.S.A., Inc. | 2015-05-14 |
| FDR D-EVO II FLAT PANEL DETECTOR SYSTEM (K142003) | Fujifilm Medical System U.S.A., Inc. | 2014-10-21 |
| FUJIFILM ENDOSCOPIC CO2 REGULATOR (K133976) | Fujifilm Medical System U.S.A., Inc. | 2014-09-09 |