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)

POLY DIAGNOST CDX

K-Number: K923654 · 1992-11-20

ApplicantXre Corp.
Decision Date1992-11-20
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POLY DIAGNOST CDX is the device name listed in this FDA 510(k) record. The listed applicant is Xre Corp.. It received FDA 510(k) clearance on 1992-11-20 under 510(k) number K923654. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY DIAGNOST CDX?

POLY DIAGNOST CDX is a medical device that received FDA 510(k) clearance on 1992-11-20. The listed applicant is Xre Corp.. The 510(k) number is K923654.

When did POLY DIAGNOST CDX receive FDA 510(k) clearance?

POLY DIAGNOST CDX received FDA 510(k) clearance on 1992-11-20, under 510(k) number K923654.

Who is the listed applicant for POLY DIAGNOST CDX?

The FDA 510(k) record lists Xre Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLY DIAGNOST CDX?

The FDA product code for POLY DIAGNOST CDX is IZI.

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 Xre Corp. 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.

K973744UNICATH SP BI-PLANE (MODEL M269 & M289)K961193FULL FRAME ZOOM SYSTEMK960998XRE COLLIMATORK945449UNICATH LLU ANGIOGRAPHIC SYSTEMK936002CINEMAC QASK933460DVFX, MODEL M256

View all 20 devices →

Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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.

↑