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FDA 510(k)

RALCO, MODEL R225 ACS

K-Number: K091517 · 2009-07-14

ApplicantRalco S.R.L.
Decision Date2009-07-14
Product CodeIZW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RALCO, MODEL R225 ACS is the device name listed in this FDA 510(k) record. The listed applicant is Ralco S.R.L.. It received FDA 510(k) clearance on 2009-07-14 under 510(k) number K091517. 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 RALCO, MODEL R225 ACS?

RALCO, MODEL R225 ACS is a medical device that received FDA 510(k) clearance on 2009-07-14. The listed applicant is Ralco S.R.L.. The 510(k) number is K091517.

When did RALCO, MODEL R225 ACS receive FDA 510(k) clearance?

RALCO, MODEL R225 ACS received FDA 510(k) clearance on 2009-07-14, under 510(k) number K091517.

Who is the listed applicant for RALCO, MODEL R225 ACS?

The FDA 510(k) record lists Ralco S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RALCO, MODEL R225 ACS?

The FDA product code for RALCO, MODEL R225 ACS is IZW.

Related Clinical Trials

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.

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Other records listing Ralco S.R.L. 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.

K110856RALCOK083029MODEL R605DASM AUTOMATIC X-RAY COLLIMATORK072780MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATORK030487R 72K946320R 302

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.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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