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FDA 510(k)

AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER

K-Number: K950667 · 1995-04-06

ApplicantChicago X-Ray Systems, Inc.
Decision Date1995-04-06
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER is the device name listed in this FDA 510(k) record. The listed applicant is Chicago X-Ray Systems, Inc.. It received FDA 510(k) clearance on 1995-04-06 under 510(k) number K950667. 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 AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER?

AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is Chicago X-Ray Systems, Inc.. The 510(k) number is K950667.

When did AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER receive FDA 510(k) clearance?

AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER received FDA 510(k) clearance on 1995-04-06, under 510(k) number K950667.

Who is the listed applicant for AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER?

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

What is the FDA product code for AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER?

The FDA product code for AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER 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 Chicago X-Ray Systems, 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.

K972968ROTOGRAPH PLUSK954565EXPLOR-X (AZTEH) HFK931300FLASH DENT

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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