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FDA 510(k)

I-MAX TOUCH 3D

K-Number: K130443 · 2013-06-14

ApplicantOwandy
Decision Date2013-06-14
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I-MAX TOUCH 3D is the device name listed in this FDA 510(k) record. The listed applicant is Owandy. It received FDA 510(k) clearance on 2013-06-14 under 510(k) number K130443. 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 I-MAX TOUCH 3D?

I-MAX TOUCH 3D is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Owandy. The 510(k) number is K130443.

When did I-MAX TOUCH 3D receive FDA 510(k) clearance?

I-MAX TOUCH 3D received FDA 510(k) clearance on 2013-06-14, under 510(k) number K130443.

Who is the listed applicant for I-MAX TOUCH 3D?

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 I-MAX TOUCH 3D?

The FDA product code for I-MAX TOUCH 3D is OAS.

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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.

K093105VISTEOK083057I-MAX TOUCHK070505KRYSTAL-X WIFIK062403IMAX CEPH DIGITAL X-RAY SENSOR

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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