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FDA 510(k)

CRANEX NOVUS

K-Number: K063459 · 2006-12-26

ApplicantSoredex Palodex Group OY
Decision Date2006-12-26
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRANEX NOVUS 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 2006-12-26 under 510(k) number K063459. 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 CRANEX NOVUS?

CRANEX NOVUS is a medical device that received FDA 510(k) clearance on 2006-12-26. The listed applicant is Soredex Palodex Group OY. The 510(k) number is K063459.

When did CRANEX NOVUS receive FDA 510(k) clearance?

CRANEX NOVUS received FDA 510(k) clearance on 2006-12-26, under 510(k) number K063459.

Who is the listed applicant for CRANEX NOVUS?

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 CRANEX NOVUS?

The FDA product code for CRANEX NOVUS is MUH.

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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.

K110839SCANORA 3DK073350SCANORA 3DK070304DIGORA PCT/DIGIPODK043307CRANEX DK040382CRANEX BASEX D OR CRANEX EXCEL DK041050DIGORA OPTIME (OR DIGORA ONTIME)

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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.

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