SYNGO IMAGING (VERSION V30)
FDA 510(k) clearance K071114 · decided 2007-05-22
Clearance details
- K-number
- K071114
- Device name
- SYNGO IMAGING (VERSION V30)
- Applicant
- Siemens AG Medical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2007-04-20
- Decision date
- 2007-05-22
- Days to decision
- 32 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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