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FDA 510(k)

MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR

K-Number: K090526 · 2009-12-02

ApplicantE-Woo Technology
Decision Date2009-12-02
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR is the device name listed in this FDA 510(k) record. The listed applicant is E-Woo Technology. It received FDA 510(k) clearance on 2009-12-02 under 510(k) number K090526. 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 MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR?

MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR is a medical device that received FDA 510(k) clearance on 2009-12-02. The listed applicant is E-Woo Technology. The 510(k) number is K090526.

When did MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR receive FDA 510(k) clearance?

MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR received FDA 510(k) clearance on 2009-12-02, under 510(k) number K090526.

Who is the listed applicant for MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR?

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

What is the FDA product code for MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR?

The FDA product code for MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR is MUH.

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Other records listing E-Woo Technology 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.

K091090DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717K090991COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUOK090171COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3DK082410MASTER3DSK081847PICASSO MASTER, ECT AND MASTER 3DK070658DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM

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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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