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FDA 510(k)

R650 QDASM COLLIMATOR

K-Number: K093572 · 2010-02-03

ApplicantOmega Medical Imaging, Inc.
Decision Date2010-02-03
Product CodeIZW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

R650 QDASM COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Imaging, Inc.. It received FDA 510(k) clearance on 2010-02-03 under 510(k) number K093572. 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 R650 QDASM COLLIMATOR?

R650 QDASM COLLIMATOR is a medical device that received FDA 510(k) clearance on 2010-02-03. The listed applicant is Omega Medical Imaging, Inc.. The 510(k) number is K093572.

When did R650 QDASM COLLIMATOR receive FDA 510(k) clearance?

R650 QDASM COLLIMATOR received FDA 510(k) clearance on 2010-02-03, under 510(k) number K093572.

Who is the listed applicant for R650 QDASM COLLIMATOR?

The FDA 510(k) record lists Omega Medical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R650 QDASM COLLIMATOR?

The FDA product code for R650 QDASM COLLIMATOR is IZW.

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Other records listing Omega Medical Imaging, Inc. as applicant

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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.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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