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FDA 510(k)

MASTER3DS

K-Number: K082410 · 2008-10-31

ApplicantE-Woo Technology
Decision Date2008-10-31
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MASTER3DS 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 2008-10-31 under 510(k) number K082410. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTER3DS?

MASTER3DS is a medical device that received FDA 510(k) clearance on 2008-10-31. The listed applicant is E-Woo Technology. The 510(k) number is K082410.

When did MASTER3DS receive FDA 510(k) clearance?

MASTER3DS received FDA 510(k) clearance on 2008-10-31, under 510(k) number K082410.

Who is the listed applicant for MASTER3DS?

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 MASTER3DS?

The FDA product code for MASTER3DS is OAS.

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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 1717K090526MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSORK090991COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUOK090171COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3DK081847PICASSO MASTER, ECT AND MASTER 3DK070658DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM

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Related Devices (Code: OAS)

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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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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