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FDA 510(k)

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

K-Number: K182533 · 2018-10-04

ApplicantPixxgen Corporation
Decision Date2018-10-04
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels is a medical device manufactured by Pixxgen Corporation. It received FDA 510(k) clearance on 2018-10-04 under approval number K182533. 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 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels?

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels is a medical device that received FDA 510(k) clearance on 2018-10-04. It is manufactured by Pixxgen Corporation. The 510(k) number is K182533.

When was PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels approved by the FDA?

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels received FDA 510(k) clearance on 2018-10-04, under approval number K182533.

What company makes PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels?

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels is manufactured by Pixxgen Corporation.

What is the FDA product code for PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels?

The FDA product code for PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels is MQB.

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Related PubMed Literature

PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026) PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026)

Other Devices by Pixxgen Corporation

K180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels K190691Pixx2430 Digital Diagnostic X-Ray Receptor Panel K211108Prudent 1717, Prudent 1417, Prudent 1212

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, 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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