ORALIX PANORAMIC D.C.
FDA 510(k) clearance K852768 · decided 1985-09-19
Clearance details
- K-number
- K852768
- Device name
- ORALIX PANORAMIC D.C.
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-28
- Decision date
- 1985-09-19
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- IZF
- Device class
- 2
- Regulation number
- 892.1740
- 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
No recalls on record reference this clearance.