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FDA 510(k)

IMAX CEPH DIGITAL X-RAY SENSOR

K-Number: K062403 · 2006-11-14

ApplicantOwandy
Decision Date2006-11-14
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMAX CEPH DIGITAL X-RAY SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Owandy. It received FDA 510(k) clearance on 2006-11-14 under 510(k) number K062403. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAX CEPH DIGITAL X-RAY SENSOR?

IMAX CEPH DIGITAL X-RAY SENSOR is a medical device that received FDA 510(k) clearance on 2006-11-14. The listed applicant is Owandy. The 510(k) number is K062403.

When did IMAX CEPH DIGITAL X-RAY SENSOR receive FDA 510(k) clearance?

IMAX CEPH DIGITAL X-RAY SENSOR received FDA 510(k) clearance on 2006-11-14, under 510(k) number K062403.

Who is the listed applicant for IMAX CEPH DIGITAL X-RAY SENSOR?

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

What is the FDA product code for IMAX CEPH DIGITAL X-RAY SENSOR?

The FDA product code for IMAX CEPH DIGITAL X-RAY SENSOR is MUH.

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 Owandy 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.

K130443I-MAX TOUCH 3DK093105VISTEOK083057I-MAX TOUCHK070505KRYSTAL-X WIFI

Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, 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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