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)

DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA

K-Number: K093640 · 2011-04-29

ApplicantElectron Jsco.
Decision Date2011-04-29
Product CodeIXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA is the device name listed in this FDA 510(k) record. The listed applicant is Electron Jsco.. It received FDA 510(k) clearance on 2011-04-29 under 510(k) number K093640. The device is classified under product code IXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA?

DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA is a medical device that received FDA 510(k) clearance on 2011-04-29. The listed applicant is Electron Jsco.. The 510(k) number is K093640.

When did DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA receive FDA 510(k) clearance?

DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA received FDA 510(k) clearance on 2011-04-29, under 510(k) number K093640.

Who is the listed applicant for DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA?

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

What is the FDA product code for DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA?

The FDA product code for DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA is IXK.

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

Related Devices (Code: IXK)

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.

K072766PVMED DDR 2520 DIGITAL IMAGING SYSTEMPortavision MedicalK042779RADIOTHERAPY SOLUTION BASED ON CRAgfa Corp.K032654PORT CASSETTEOrex Computed Radiography, Ltd.K003689CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31Canon USA, Inc.K000159AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLOAgfa Corp.K942561FUJI FCR IMAGE PROCESSING UNIT IP-U515Fujifilm Medical System U.S.A., 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.

↑