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FDA 510(k)

OMNI PLANE SYSTEM

K-Number: K854085 · 1985-10-28

ApplicantXre Corp.
Decision Date1985-10-28
Product CodeIXR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNI PLANE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xre Corp.. It received FDA 510(k) clearance on 1985-10-28 under 510(k) number K854085. The device is classified under product code IXR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI PLANE SYSTEM?

OMNI PLANE SYSTEM is a medical device that received FDA 510(k) clearance on 1985-10-28. The listed applicant is Xre Corp.. The 510(k) number is K854085.

When did OMNI PLANE SYSTEM receive FDA 510(k) clearance?

OMNI PLANE SYSTEM received FDA 510(k) clearance on 1985-10-28, under 510(k) number K854085.

Who is the listed applicant for OMNI PLANE SYSTEM?

The FDA 510(k) record lists Xre Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNI PLANE SYSTEM?

The FDA product code for OMNI PLANE SYSTEM is IXR.

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Other records listing Xre Corp. 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.

K973744UNICATH SP BI-PLANE (MODEL M269 & M289)K961193FULL FRAME ZOOM SYSTEMK960998XRE COLLIMATORK945449UNICATH LLU ANGIOGRAPHIC SYSTEMK936002CINEMAC QASK933460DVFX, MODEL M256

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Related Devices (Code: IXR)

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.

K000412VISION R/F TILTING TABLEVilla Sistemi Medicali S.P.A.K973039LEGACY/LEGACY-D TABLEGE Medical SystemsK971128CAP-35B III/CINE 275Jamieson Film Co.K970640PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.K965105ELECTROPHYSIOLOGY TILT TABLE MODEL #9660U.S. Imaging Tables, Inc.K965096FLUOROVIEW SERIES FLUOROSCOPIC TABLESU.S. Imaging Tables, Inc.

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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