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FDA 510(k)

R605 FACS COLLIMETER

K-Number: K050092 · 2005-01-31

ApplicantOmega Medical Imaging, Inc.
Decision Date2005-01-31
Product CodeIZW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

R605 FACS COLLIMETER 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 2005-01-31 under 510(k) number K050092. 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 R605 FACS COLLIMETER?

R605 FACS COLLIMETER is a medical device that received FDA 510(k) clearance on 2005-01-31. The listed applicant is Omega Medical Imaging, Inc.. The 510(k) number is K050092.

When did R605 FACS COLLIMETER receive FDA 510(k) clearance?

R605 FACS COLLIMETER received FDA 510(k) clearance on 2005-01-31, under 510(k) number K050092.

Who is the listed applicant for R605 FACS COLLIMETER?

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 R605 FACS COLLIMETER?

The FDA product code for R605 FACS COLLIMETER is IZW.

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Other records listing Omega Medical Imaging, Inc. 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.

K100102CS-SERIES-FPK093572R650 QDASM COLLIMATORK070834CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)K062647E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50K990055B-400 CEILING MOUNTED POSSITIONER, MODEL B-400K970947B-350 CEILING MOUNTED C-POSITIONER

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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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