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FDA 510(k)

COLLIMAX X-RAY COLLIMATOR # R-182

K-Number: K801168 · 1980-07-08

ApplicantIto X-Ray Corp.
Decision Date1980-07-08
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COLLIMAX X-RAY COLLIMATOR # R-182 is the device name listed in this FDA 510(k) record. The listed applicant is Ito X-Ray Corp.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801168. The device is classified under product code IZX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLIMAX X-RAY COLLIMATOR # R-182?

COLLIMAX X-RAY COLLIMATOR # R-182 is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Ito X-Ray Corp.. The 510(k) number is K801168.

When did COLLIMAX X-RAY COLLIMATOR # R-182 receive FDA 510(k) clearance?

COLLIMAX X-RAY COLLIMATOR # R-182 received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801168.

Who is the listed applicant for COLLIMAX X-RAY COLLIMATOR # R-182?

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

What is the FDA product code for COLLIMAX X-RAY COLLIMATOR # R-182?

The FDA product code for COLLIMAX X-RAY COLLIMATOR # R-182 is IZX.

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Related Devices (Code: IZX)

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.

K110856RALCORalco S.R.L.K101036SHIMADZU COLLIMATOR R-20JShimadzu Corp.K042840SHIMADZU COLLIMATOR R-20JShimadzu Corp.K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.K981267FACTS MONOBLOCKDynarad Corp.K974240LIGHTLINE-MWuestec Medical, Inc.

Official Source

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

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