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FDA 510(k)

RALCO

K-Number: K110856 · 2011-08-10

ApplicantRalco S.R.L.
Decision Date2011-08-10
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RALCO 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 2011-08-10 under 510(k) number K110856. The device is classified under product code IZX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RALCO?

RALCO is a medical device that received FDA 510(k) clearance on 2011-08-10. The listed applicant is Ralco S.R.L.. The 510(k) number is K110856.

When did RALCO receive FDA 510(k) clearance?

RALCO received FDA 510(k) clearance on 2011-08-10, under 510(k) number K110856.

Who is the listed applicant for RALCO?

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?

The FDA product code for RALCO is IZX.

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.

K091517RALCO, MODEL R225 ACSK083029MODEL R605DASM AUTOMATIC X-RAY COLLIMATORK072780MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATORK030487R 72K946320R 302

Related Devices (Code: IZX)

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-20JShimadzu Corp.K042840SHIMADZU COLLIMATOR R-20JShimadzu Corp.K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.K981267FACTS MONOBLOCKDynarad Corp.K974240LIGHTLINE-MWuestec Medical, Inc.K972966AXT 150M MANUAL COLLIMATOR (AXT 150M)Applied X-Ray Technologies, Inc.

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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