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FDA 510(k)

Orthopantomograph OP 3D

K-Number: K180947 · 2018-06-07

ApplicantPalodex Group OY
Decision Date2018-06-07
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Orthopantomograph OP 3D is the device name listed in this FDA 510(k) record. The listed applicant is Palodex Group OY. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K180947. 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 Orthopantomograph OP 3D?

Orthopantomograph OP 3D is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Palodex Group OY. The 510(k) number is K180947.

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

Orthopantomograph OP 3D received FDA 510(k) clearance on 2018-06-07, under 510(k) number K180947.

Who is the listed applicant for Orthopantomograph OP 3D?

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

What is the FDA product code for Orthopantomograph OP 3D?

The FDA product code for Orthopantomograph OP 3D is OAS.

Other records listing 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.

K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)K230505Orthopantomograph™ OP 3D LXK173646FS ErgoK163423Orthopantomograph OP300K162799CliniviewK170813ORTHOPANTOMOGRAPH OP 3D

View all 7 devices →

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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