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FDA 510(k)

Pixx2430 Digital Diagnostic X-Ray Receptor Panel

K-Number: K190691 · 2019-04-04

ApplicantPixxgen Corporation
Decision Date2019-04-04
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Pixx2430 Digital Diagnostic X-Ray Receptor Panel is the device name listed in this FDA 510(k) record. The listed applicant is Pixxgen Corporation. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K190691. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pixx2430 Digital Diagnostic X-Ray Receptor Panel?

Pixx2430 Digital Diagnostic X-Ray Receptor Panel is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Pixxgen Corporation. The 510(k) number is K190691.

When did Pixx2430 Digital Diagnostic X-Ray Receptor Panel receive FDA 510(k) clearance?

Pixx2430 Digital Diagnostic X-Ray Receptor Panel received FDA 510(k) clearance on 2019-04-04, under 510(k) number K190691.

Who is the listed applicant for Pixx2430 Digital Diagnostic X-Ray Receptor Panel?

The FDA 510(k) record lists Pixxgen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pixx2430 Digital Diagnostic X-Ray Receptor Panel?

The FDA product code for Pixx2430 Digital Diagnostic X-Ray Receptor Panel is MQB.

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.

NCT07631377The LalelaLung Study: Digital Stethoscope Clinical EvaluationNOT_YET_RECRUITINGNCT07640568Parent-led Assessment and Recognition of AOM Using Digital Ear ImagingNOT_YET_RECRUITING

Other records listing Pixxgen Corporation 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.

K211108Prudent 1717, Prudent 1417, Prudent 1212K182533PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsK180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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