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FDA 510(k)

SHIMADZU COLLIMATOR R-20J

K-Number: K042840 · 2004-12-03

ApplicantShimadzu Corp.
Decision Date2004-12-03
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU COLLIMATOR R-20J is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 2004-12-03 under 510(k) number K042840. 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 SHIMADZU COLLIMATOR R-20J?

SHIMADZU COLLIMATOR R-20J is a medical device that received FDA 510(k) clearance on 2004-12-03. The listed applicant is Shimadzu Corp.. The 510(k) number is K042840.

When did SHIMADZU COLLIMATOR R-20J receive FDA 510(k) clearance?

SHIMADZU COLLIMATOR R-20J received FDA 510(k) clearance on 2004-12-03, under 510(k) number K042840.

Who is the listed applicant for SHIMADZU COLLIMATOR R-20J?

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

What is the FDA product code for SHIMADZU COLLIMATOR R-20J?

The FDA product code for SHIMADZU COLLIMATOR R-20J is IZX.

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Other records listing Shimadzu 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.

K101039SHIMADZU COLLIMATOR R-300K101036SHIMADZU COLLIMATOR R-20JK090578SHIMADZU COLLIMATOR R-30HK090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONK080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONK072006DAR-9400F

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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.K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.K981267FACTS MONOBLOCKDynarad Corp.K974240LIGHTLINE-MWuestec Medical, Inc.K972966AXT 150M MANUAL COLLIMATOR (AXT 150M)Applied X-Ray Technologies, 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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