SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P030010/S002 · decided 2005-06-20
Approval details
- PMA number
- P030010
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2005-05-20
- Decision date
- 2005-06-20
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- APPROVAL FOR LABELING CHANGES TO THE OPERATORS MANUAL WHICH ADD OR STRENGTHEN A CONTRAINDICATION, WARNING, PRECAUTION, OR INFORMATION ABOUT AN ADVERSE REACTION AND ADD OR STRENGTHEN AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
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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 |