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FDA 510(k)

DIGORA

K-Number: K934949 · 1994-02-10

ApplicantOrion Corporation Soredex
Decision Date1994-02-10
Product CodeIXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGORA is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corporation Soredex. It received FDA 510(k) clearance on 1994-02-10 under 510(k) number K934949. 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 DIGORA?

DIGORA is a medical device that received FDA 510(k) clearance on 1994-02-10. The listed applicant is Orion Corporation Soredex. The 510(k) number is K934949.

When did DIGORA receive FDA 510(k) clearance?

DIGORA received FDA 510(k) clearance on 1994-02-10, under 510(k) number K934949.

Who is the listed applicant for DIGORA?

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

What is the FDA product code for DIGORA?

The FDA product code for DIGORA 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

Other records listing Orion Corporation Soredex 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.

K983267DIGORA FOR WINDOWS 2.0K974877CRANEX TOME CEPH, OR CRANEX TOMEK880982ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY

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.

K093640DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRAElectron Jsco.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.

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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