PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
FDA 510(k) clearance K031333 · decided 2003-05-13
Clearance details
- K-number
- K031333
- Device name
- PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
- Applicant
- Philips Medical Systems North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-28
- Decision date
- 2003-05-13
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Da Best, NL
- Third-party review
- Yes
- Expedited review
- No
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