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Chison Medical Imaging Co., Ltd.

FDA Regulatory Profile

Chison Medical Imaging Co., Ltd. has 0 FDA recalls, 1 inspection, 13 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 15, 2015 · NAI
Latest 510(k)
Jul 6, 2017

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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) clearances13Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 15, 2015Wuxi, ChinaDevicesNo Action Indicated (NAI)3008528369

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
K170870Site~Rite Halcyon Diagnostic Ultrasound SystemJul 6, 2017
K170374SonoBook Series Diagnostic Ultrasound SystemJun 6, 2017
K162172EBit Series Diagnostic Ultrasound SystemSep 14, 2016
K153085Q Series Diagnostic Ultrasound SystemDec 21, 2015
K150861QBit Series Diagnostic Ultrasound SystemJul 28, 2015
K140364CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND…Jun 2, 2014
K131305CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBEAug 1, 2013
K121867SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMSAug 2, 2012
K120801CHISON DIAGNOSTIC ULTRASOUND SYSTEMJun 14, 2012
K113359CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBEFeb 3, 2012
K091877CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE…Sep 2, 2009
K072210CHISON, MODEL 8300Aug 24, 2007
K050167CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBEFeb 8, 2005

FDA data resources