SYNGO.PLAZA
FDA 510(k) clearance K093612 · decided 2010-03-04
Clearance details
- K-number
- K093612
- Device name
- SYNGO.PLAZA
- Applicant
- Siemens AG Medical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2009-11-23
- Decision date
- 2010-03-04
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Erlangen, DE
- Third-party review
- Yes
- Expedited review
- No
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