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FDA 510(k)

MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR

K-Number: K083029 · 2008-12-05

ApplicantRalco S.R.L.
Decision Date2008-12-05
Product CodeIZW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR 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 2008-12-05 under 510(k) number K083029. 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 MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR?

MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is Ralco S.R.L.. The 510(k) number is K083029.

When did MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR receive FDA 510(k) clearance?

MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR received FDA 510(k) clearance on 2008-12-05, under 510(k) number K083029.

Who is the listed applicant for MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR?

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 MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR?

The FDA product code for MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K110856RALCOK091517RALCO, MODEL R225 ACSK072780MODEL 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.K091517RALCO, MODEL R225 ACSRalco 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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