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FDA 510(k)

R-100-ET MANUAL COLLIMATOR

K-Number: K900007 · 1990-02-06

ApplicantAdvantech
Decision Date1990-02-06
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

R-100-ET MANUAL COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Advantech. It received FDA 510(k) clearance on 1990-02-06 under 510(k) number K900007. 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 R-100-ET MANUAL COLLIMATOR?

R-100-ET MANUAL COLLIMATOR is a medical device that received FDA 510(k) clearance on 1990-02-06. The listed applicant is Advantech. The 510(k) number is K900007.

When did R-100-ET MANUAL COLLIMATOR receive FDA 510(k) clearance?

R-100-ET MANUAL COLLIMATOR received FDA 510(k) clearance on 1990-02-06, under 510(k) number K900007.

Who is the listed applicant for R-100-ET MANUAL COLLIMATOR?

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

What is the FDA product code for R-100-ET MANUAL COLLIMATOR?

The FDA product code for R-100-ET MANUAL COLLIMATOR 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 Advantech 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.

K904182R-800-SFK896486R-150-ET COLLIMATOR

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.

K110856RALCORalco S.R.L.K101036SHIMADZU COLLIMATOR R-20JShimadzu Corp.K042840SHIMADZU COLLIMATOR R-20JShimadzu Corp.K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.K981267FACTS MONOBLOCKDynarad Corp.K974240LIGHTLINE-MWuestec Medical, 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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