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Pixxgen Corporation

FDA Regulatory Profile

Pixxgen Corporation has 0 FDA recalls, 2 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 16, 2020 · OAI
Latest 510(k)
Jun 4, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 16, 2020Anyang, Korea (The Republic Of)DevicesOfficial Action Indicated (OAI)3008164200
Jun 26, 2013Anyang, Korea (The Republic Of)DevicesNo Action Indicated (NAI)3008164200

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K211108Prudent 1717, Prudent 1417, Prudent 1212Jun 4, 2021
K190691Pixx2430 Digital Diagnostic X-Ray Receptor PanelApr 4, 2019
K182533PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsOct 4, 2018
K180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsMay 24, 2018

FDA data resources