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FDA 510(k)

X-RAY TUBE - PANOBEAM

K-Number: K770345 · 1977-03-08

ApplicantThoro-Ray, Inc.
Decision Date1977-03-08
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-RAY TUBE - PANOBEAM is the device name listed in this FDA 510(k) record. The listed applicant is Thoro-Ray, Inc.. It received FDA 510(k) clearance on 1977-03-08 under 510(k) number K770345. 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 X-RAY TUBE - PANOBEAM?

X-RAY TUBE - PANOBEAM is a medical device that received FDA 510(k) clearance on 1977-03-08. The listed applicant is Thoro-Ray, Inc.. The 510(k) number is K770345.

When did X-RAY TUBE - PANOBEAM receive FDA 510(k) clearance?

X-RAY TUBE - PANOBEAM received FDA 510(k) clearance on 1977-03-08, under 510(k) number K770345.

Who is the listed applicant for X-RAY TUBE - PANOBEAM?

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

What is the FDA product code for X-RAY TUBE - PANOBEAM?

The FDA product code for X-RAY TUBE - PANOBEAM 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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