SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P030010 · decided 2004-08-20
Approval details
- PMA number
- P030010
- Trade name
- SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Siemens Medical Solution
- Date received
- 2003-04-10
- Decision date
- 2004-08-20
- Days to decision
- 498 days
- Decision code
- APRL
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- APPROVAL FOR THE SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER AND IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHIC SYSTEMS. THESE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY EITHER HARDCOPY FILM OR BY SOFTCOPY AT A WORKSTATION.
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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 |