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FDA 510(k)

SHIMADZU COLLIMATOR R-300

K-Number: K101039 · 2010-09-20

ApplicantShimadzu Corp.
Decision Date2010-09-20
Product CodeIZW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU COLLIMATOR R-300 is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 2010-09-20 under 510(k) number K101039. 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 SHIMADZU COLLIMATOR R-300?

SHIMADZU COLLIMATOR R-300 is a medical device that received FDA 510(k) clearance on 2010-09-20. The listed applicant is Shimadzu Corp.. The 510(k) number is K101039.

When did SHIMADZU COLLIMATOR R-300 receive FDA 510(k) clearance?

SHIMADZU COLLIMATOR R-300 received FDA 510(k) clearance on 2010-09-20, under 510(k) number K101039.

Who is the listed applicant for SHIMADZU COLLIMATOR R-300?

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-300?

The FDA product code for SHIMADZU COLLIMATOR R-300 is IZW.

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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.

K101036SHIMADZU COLLIMATOR R-20JK090578SHIMADZU COLLIMATOR R-30HK090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONK080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONK072006DAR-9400FK071717GE OEC ALTITUDE

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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.

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.K073124COLLIMARE COLLIMATOR FAMILYCollimare, LLC

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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