SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P030010/S006 · decided 2010-11-05
Approval details
- PMA number
- P030010
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Siemens Medical Solution
- Date received
- 2009-10-13
- Decision date
- 2010-11-05
- Days to decision
- 388 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- APPROVAL FOR CHANGING THE OEM COMPONENTS (DETECTOR AND IMAGE PROCESSING) DEVELOPED BY LORAD, THE MAMMOMAT NOVATION, TO AN FFDM SYSTEM THAT IS DESIGNED SOLELY FROM COMPONENTS DESIGNED OR SPECIFIED BY SIEMENS, THE MAMMOMAT INSPIRATION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MULTIX FUSION (K121513) | Siemens Medical Solution | 2012-08-10 |
| ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM (K121138) | Siemens Medical Solution | 2012-05-17 |
| SYNGO EXPERT-1 (K061449) | Siemens Medical Solution | 2006-07-25 |
| MAGNETOM SYMPHONY A TIM SYSTEM (K050199) | Siemens Medical Solution | 2005-02-18 |