NEUROSPECTQUAD GAMMA CAMERA
FDA 510(k) clearance K013353 · decided 2002-03-04
Clearance details
- K-number
- K013353
- Device name
- NEUROSPECTQUAD GAMMA CAMERA
- Applicant
- Nuclear Cardiology Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-09
- Decision date
- 2002-03-04
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.