ORTHORALIX SD/ORTHORALIX SD CEPH— 510(k) K890351
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K890351 for ORTHORALIX SD/ORTHORALIX SD CEPH, Substantially Equivalent on 1989-06-15. Applicant: Philips Medical Systems North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code IZF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1740
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.