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FDA 510(k)

SCANORA 3D

K-Number: K110839 · 2011-06-30

ApplicantSoredex Palodex Group OY
Decision Date2011-06-30
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCANORA 3D is the device name listed in this FDA 510(k) record. The listed applicant is Soredex Palodex Group OY. It received FDA 510(k) clearance on 2011-06-30 under 510(k) number K110839. 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 SCANORA 3D?

SCANORA 3D is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Soredex Palodex Group OY. The 510(k) number is K110839.

When did SCANORA 3D receive FDA 510(k) clearance?

SCANORA 3D received FDA 510(k) clearance on 2011-06-30, under 510(k) number K110839.

Who is the listed applicant for SCANORA 3D?

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

What is the FDA product code for SCANORA 3D?

The FDA product code for SCANORA 3D is OAS.

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Other records listing Soredex Palodex Group OY 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.

K073350SCANORA 3DK070304DIGORA PCT/DIGIPODK063459CRANEX NOVUSK043307CRANEX DK040382CRANEX BASEX D OR CRANEX EXCEL DK041050DIGORA OPTIME (OR DIGORA ONTIME)

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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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