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FDA 510(k)

XRE COLLIMATOR

K-Number: K960998 · 1996-04-03

ApplicantXre Corp.
Decision Date1996-04-03
Product CodeIZW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XRE COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Xre Corp.. It received FDA 510(k) clearance on 1996-04-03 under 510(k) number K960998. The device is classified under product code IZW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XRE COLLIMATOR?

XRE COLLIMATOR is a medical device that received FDA 510(k) clearance on 1996-04-03. The listed applicant is Xre Corp.. The 510(k) number is K960998.

When did XRE COLLIMATOR receive FDA 510(k) clearance?

XRE COLLIMATOR received FDA 510(k) clearance on 1996-04-03, under 510(k) number K960998.

Who is the listed applicant for XRE COLLIMATOR?

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 XRE COLLIMATOR?

The FDA product code for XRE COLLIMATOR is IZW.

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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 SYSTEMK945449UNICATH LLU ANGIOGRAPHIC SYSTEMK936002CINEMAC QASK933460DVFX, MODEL M256K924828BI-N

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Related Devices (Code: IZW)

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.

K101039SHIMADZU COLLIMATOR R-300Shimadzu Corp.K093572R650 QDASM COLLIMATOROmega Medical Imaging, Inc.K090578SHIMADZU COLLIMATOR R-30HShimadzu Corp.K091517RALCO, MODEL R225 ACSRalco S.R.L.K083029MODEL R605DASM AUTOMATIC X-RAY COLLIMATORRalco S.R.L.K072780MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATORRalco S.R.L.

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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