MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
FDA 510(k) clearance K033956 · decided 2004-01-20
Clearance details
- K-number
- K033956
- Device name
- MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
- Applicant
- Is2 Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-22
- Decision date
- 2004-01-20
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ottawa, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.