MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
FDA 510(k) clearance K072468 · decided 2007-10-01
Clearance details
- K-number
- K072468
- Device name
- MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
- Applicant
- Spectrum Dynamics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-04
- Decision date
- 2007-10-01
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kfar Saba, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System - recall (Z-1214-2012) | Spectrum Dynamics | 2012-03-21 |