SYNGO IMAGING XS
FDA 510(k) clearance K082430 · decided 2008-11-14
Clearance details
- K-number
- K082430
- Device name
- SYNGO IMAGING XS
- Applicant
- Siemens AG Medical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2008-08-22
- Decision date
- 2008-11-14
- Days to decision
- 84 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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