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)

SCANORA 3D

K-Number: K073350 · 2007-12-19

ApplicantSoredex Palodex Group OY
Decision Date2007-12-19
Product CodeMUH
Advisory CommitteeDE
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 2007-12-19 under 510(k) number K073350. The device is classified under product code MUH. It was reviewed by the DE 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 2007-12-19. The listed applicant is Soredex Palodex Group OY. The 510(k) number is K073350.

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

SCANORA 3D received FDA 510(k) clearance on 2007-12-19, under 510(k) number K073350.

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 MUH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K110839SCANORA 3DK070304DIGORA PCT/DIGIPODK063459CRANEX NOVUSK043307CRANEX DK040382CRANEX BASEX D OR CRANEX EXCEL DK041050DIGORA OPTIME (OR DIGORA ONTIME)

View all 9 devices →

Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

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.

↑