Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INTREX INTERORAL DENTAL X-RAY UNIT

K-Number: K930925 · 1993-07-13

ApplicantKeystone X-Ray, Inc.
Decision Date1993-07-13
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTREX 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 1993-07-13 under 510(k) number K930925. 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 INTERORAL DENTAL X-RAY UNIT?

INTREX INTERORAL DENTAL X-RAY UNIT is a medical device that received FDA 510(k) clearance on 1993-07-13. The listed applicant is Keystone X-Ray, Inc.. The 510(k) number is K930925.

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

INTREX INTERORAL DENTAL X-RAY UNIT received FDA 510(k) clearance on 1993-07-13, under 510(k) number K930925.

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

The FDA product code for INTREX 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.

K931486INTREX VSK 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

View on FDA Database →

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

↑