Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OP300

K-Number: K122018 · 2012-12-10

ApplicantPalodex Group OY
Decision Date2012-12-10
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OP300 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 2012-12-10 under 510(k) number K122018. 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 OP300?

OP300 is a medical device that received FDA 510(k) clearance on 2012-12-10. The listed applicant is Palodex Group OY. The 510(k) number is K122018.

When did OP300 receive FDA 510(k) clearance?

OP300 received FDA 510(k) clearance on 2012-12-10, under 510(k) number K122018.

Who is the listed applicant for OP300?

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 OP300?

The FDA product code for OP300 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 LXK180947Orthopantomograph OP 3DK173646FS ErgoK163423Orthopantomograph OP300K162799Cliniview

View all 9 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.

↑