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FDA 510(k)

ORTHORALIX SD/ORTHORALIX SD CEPH

K-Number: K890351 · 1989-06-15

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1989-06-15
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHORALIX SD/ORTHORALIX SD CEPH is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1989-06-15 under 510(k) number K890351. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHORALIX SD/ORTHORALIX SD CEPH?

ORTHORALIX SD/ORTHORALIX SD CEPH is a medical device that received FDA 510(k) clearance on 1989-06-15. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K890351.

When did ORTHORALIX SD/ORTHORALIX SD CEPH receive FDA 510(k) clearance?

ORTHORALIX SD/ORTHORALIX SD CEPH received FDA 510(k) clearance on 1989-06-15, under 510(k) number K890351.

Who is the listed applicant for ORTHORALIX SD/ORTHORALIX SD CEPH?

The FDA 510(k) record lists Philips Medical Systems North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHORALIX SD/ORTHORALIX SD CEPH?

The FDA product code for ORTHORALIX SD/ORTHORALIX SD CEPH is IZF.

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Other records listing Philips Medical Systems North America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102005ALLURA XPER OR TABLE SERIESK062233HEARTSTART MRX MONITOR/DEFIBRILLATORK062283THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORSK061052THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90K050151MULTIDIAGNOST ELEVAK042867PHILIPS ORTHOPAEDIC APPLICATIONS

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Related Devices (Code: IZF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252649TAP2DNano-X Imaging , Ltd.K252133Adaptix Ortho350Adaptix LimitedK250850Nanox.ARC XNano-X Imaging , Ltd.K242395Nanox.ARCNano-X Imaging , Ltd.K222934Nanox.ARCNano-X Imaging , Ltd.K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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