DST-XL
FDA 510(k) clearance K942837 · decided 1995-01-05
Clearance details
- K-number
- K942837
- Device name
- DST-XL
- Applicant
- Sopha Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-15
- Decision date
- 1995-01-05
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contourin recall (Z-2008-2008) | GE Healthcare | 2008-09-05 |
| Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System recall (Z-0105-06) | General Electric Med Systems LLC | 2005-10-28 |