PANORAMA 1.0T
FDA 510(k) clearance K041602 · decided 2004-07-26
Clearance details
- K-number
- K041602
- Device name
- PANORAMA 1.0T
- Applicant
- Philips Medical Systems North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-14
- Decision date
- 2004-07-26
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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