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FDA 510(k)

Orthopantomograph™ OP 3D LX

K-Number: K230505 · 2023-06-09

ApplicantPalodex Group OY
Decision Date2023-06-09
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Orthopantomograph™ OP 3D LX 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 2023-06-09 under 510(k) number K230505. 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 LX?

Orthopantomograph™ OP 3D LX is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Palodex Group OY. The 510(k) number is K230505.

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

Orthopantomograph™ OP 3D LX received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230505.

Who is the listed applicant for Orthopantomograph™ OP 3D LX?

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 LX?

The FDA product code for Orthopantomograph™ OP 3D LX 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)K180947Orthopantomograph OP 3DK173646FS 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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