PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
FDA 510(k) clearance K022899 · decided 2002-11-22
Clearance details
- K-number
- K022899
- Device name
- PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
- Applicant
- Philips Medical Systems North America Co.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-03
- Decision date
- 2002-11-22
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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