FDA 510(k)

JAZZ SOLO Sensor

Numéro K : K163224 · 2017-03-09

Date de décision2017-03-09

Code produitMUH

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

JAZZ SOLO Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Jazz Imaging, LLC. It received FDA 510(k) clearance on 2017-03-09 under 510(k) number K163224. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the JAZZ SOLO Sensor?

JAZZ SOLO Sensor is a medical device that received FDA 510(k) clearance on 2017-03-09. The listed applicant is Jazz Imaging, LLC. The 510(k) number is K163224.

When did JAZZ SOLO Sensor receive FDA 510(k) clearance?

JAZZ SOLO Sensor received FDA 510(k) clearance on 2017-03-09, under 510(k) number K163224.

Who is the listed applicant for JAZZ SOLO Sensor?

The FDA 510(k) record lists Jazz Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZ SOLO Sensor?

The FDA product code for JAZZ SOLO Sensor is MUH.

Essais cliniques associés

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Dispositifs connexes (Code : MUH)

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.

Source officielle

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