PHILIPS DSI SYSTEM RELEASE 3.2
FDA 510(k) clearance K920793 · decided 1992-07-17
Clearance details
- K-number
- K920793
- Device name
- PHILIPS DSI SYSTEM RELEASE 3.2
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-21
- Decision date
- 1992-07-17
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- IZJ
- Device class
- 2
- Regulation number
- 892.1620
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- 5680 Da Best, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to c recall (Z-2406-2010) | Philips Medical Systems North America Co. Phillips | 2010-09-13 |
| General X-Ray System types with Digital Spot Imaging (DSI) software recall (Z-2160-2008) | Philips Medical Systems North America Co. Phillips | 2008-08-25 |