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FDA 510(k)

INTREX VSK INTERORAL DENTAL X-RAY UNIT

K-Number: K931486 · 1993-11-23

ApplicantKeystone X-Ray, Inc.
Decision Date1993-11-23
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTREX VSK INTERORAL DENTAL X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Keystone X-Ray, Inc.. It received FDA 510(k) clearance on 1993-11-23 under 510(k) number K931486. 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 INTREX VSK INTERORAL DENTAL X-RAY UNIT?

INTREX VSK INTERORAL DENTAL X-RAY UNIT is a medical device that received FDA 510(k) clearance on 1993-11-23. The listed applicant is Keystone X-Ray, Inc.. The 510(k) number is K931486.

When did INTREX VSK INTERORAL DENTAL X-RAY UNIT receive FDA 510(k) clearance?

INTREX VSK INTERORAL DENTAL X-RAY UNIT received FDA 510(k) clearance on 1993-11-23, under 510(k) number K931486.

Who is the listed applicant for INTREX VSK INTERORAL DENTAL X-RAY UNIT?

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

What is the FDA product code for INTREX VSK INTERORAL DENTAL X-RAY UNIT?

The FDA product code for INTREX VSK INTERORAL DENTAL X-RAY UNIT is EAP.

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 Keystone X-Ray, 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.

K930925INTREX INTERORAL DENTAL X-RAY UNITK883354VARIABLE KV INTREX VSK 60 - 90 KVPK812217FLUORO AUTOMATIC BRIGHTNESS SYS

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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