AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
FDA 510(k) clearance K010721 · decided 2001-03-30
Clearance details
- K-number
- K010721
- Device name
- AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
- Applicant
- Siemens Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-12
- Decision date
- 2001-03-30
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
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