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FDA 510(k)

RADWORKS

K-Number: K934645 · 1994-08-17

ApplicantRadworks Corp.
Decision Date1994-08-17
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RADWORKS is the device name listed in this FDA 510(k) record. The listed applicant is Radworks Corp.. It received FDA 510(k) clearance on 1994-08-17 under 510(k) number K934645. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADWORKS?

RADWORKS is a medical device that received FDA 510(k) clearance on 1994-08-17. The listed applicant is Radworks Corp.. The 510(k) number is K934645.

When did RADWORKS receive FDA 510(k) clearance?

RADWORKS received FDA 510(k) clearance on 1994-08-17, under 510(k) number K934645.

Who is the listed applicant for RADWORKS?

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

What is the FDA product code for RADWORKS?

The FDA product code for RADWORKS is EAP.

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Related Devices (Code: EAP)

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.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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