SOMATOM P30 CT SYSTEMS
FDA 510(k) clearance K013522 · decided 2001-11-07
Clearance details
- K-number
- K013522
- Device name
- SOMATOM P30 CT SYSTEMS
- Applicant
- Siemens Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-23
- Decision date
- 2001-11-07
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Iselin, NJ, US
- Third-party review
- Yes
- Expedited review
- No
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