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FDA 510(k)

EXPLOR-X (AZTEH) HF

K-Number: K954565 · 1995-10-27

ApplicantChicago X-Ray Systems, Inc.
Decision Date1995-10-27
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXPLOR-X (AZTEH) HF 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 1995-10-27 under 510(k) number K954565. 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 EXPLOR-X (AZTEH) HF?

EXPLOR-X (AZTEH) HF is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is Chicago X-Ray Systems, Inc.. The 510(k) number is K954565.

When did EXPLOR-X (AZTEH) HF receive FDA 510(k) clearance?

EXPLOR-X (AZTEH) HF received FDA 510(k) clearance on 1995-10-27, under 510(k) number K954565.

Who is the listed applicant for EXPLOR-X (AZTEH) HF?

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 EXPLOR-X (AZTEH) HF?

The FDA product code for EXPLOR-X (AZTEH) HF 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 PLUSK950667AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMERK931300FLASH 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

View on FDA Database →

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

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