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FDA 510(k)

CORNEOMAP 4500

K-Number: K844299 · 1985-04-18

ApplicantRadionics Medical, Inc.
Decision Date1985-04-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CORNEOMAP 4500 is the device name listed in this FDA 510(k) record. The listed applicant is Radionics Medical, Inc.. It received FDA 510(k) clearance on 1985-04-18 under 510(k) number K844299. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNEOMAP 4500?

CORNEOMAP 4500 is a medical device that received FDA 510(k) clearance on 1985-04-18. The listed applicant is Radionics Medical, Inc.. The 510(k) number is K844299.

When did CORNEOMAP 4500 receive FDA 510(k) clearance?

CORNEOMAP 4500 received FDA 510(k) clearance on 1985-04-18, under 510(k) number K844299.

Who is the listed applicant for CORNEOMAP 4500?

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

What is the FDA product code for CORNEOMAP 4500?

The FDA product code for CORNEOMAP 4500 is IYO.

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 Radionics Medical, 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.

K833222SINUSVU 2500K837331CORNEOMAP 4500 ULTRASOUND MEASUREMENTK827035OCULAR BIOMETER 4000K810851SPECTRUM ANALYZER 8000

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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