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FDA 510(k)

VERSATOME

K-Number: K771549 · 1977-08-25

ApplicantKermath Mfg. Corp.
Decision Date1977-08-25
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERSATOME is the device name listed in this FDA 510(k) record. The listed applicant is Kermath Mfg. Corp.. It received FDA 510(k) clearance on 1977-08-25 under 510(k) number K771549. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSATOME?

VERSATOME is a medical device that received FDA 510(k) clearance on 1977-08-25. The listed applicant is Kermath Mfg. Corp.. The 510(k) number is K771549.

When did VERSATOME receive FDA 510(k) clearance?

VERSATOME received FDA 510(k) clearance on 1977-08-25, under 510(k) number K771549.

Who is the listed applicant for VERSATOME?

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

What is the FDA product code for VERSATOME?

The FDA product code for VERSATOME is IZF.

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 Kermath Mfg. Corp. 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.

K870221T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)K812726KERMATH THERAPY SIMULATORK812332KERMATH L/C ARMK811215KERMATH RADIOGRAPHIC HEAD STAND

Related Devices (Code: IZF)

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.

K252649TAP2DNano-X Imaging , Ltd.K252133Adaptix Ortho350Adaptix LimitedK250850Nanox.ARC XNano-X Imaging , Ltd.K242395Nanox.ARCNano-X Imaging , Ltd.K222934Nanox.ARCNano-X Imaging , Ltd.K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH

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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