Home / Companies / Minxray, Inc.

Minxray, Inc.

FDA Regulatory Profile

Minxray, Inc. has 0 FDA recalls, 2 inspections, 18 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 2, 2022 · VAI
Latest 510(k)
Mar 19, 2021

Reviewing Minxray, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Minxray, Inc.'s full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances18Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 2, 2022Northbrook, ILDevicesVoluntary Action Indicated (VAI)1418960
Dec 10, 2018Northbrook, ILDevicesNo Action Indicated (NAI)1418960

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
K210479IMPACT and X-RangerMar 19, 2021
K201575CMDR 2C (Multiple Models)Jul 8, 2020
K191451CMDR 2CW (Multiple models)Jul 3, 2019
K182207TR90BHDec 14, 2018
K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisJun 7, 2017
K153059HF1202H PowerPlus Portable X-ray EquipmentFeb 2, 2016
K141885CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAYSep 18, 2014
K091255MINXRAY, MODEL: BPD60May 12, 2010
K100449MINXRAY MODEL CMDR-2SApr 23, 2010
K082627MINXRAY, MODEL CMDR-1S AND CMDR-1S-MILNov 7, 2008
K052721MINXRAY, MODEL HF100H+Oct 27, 2005
K040046MINXRAY, MODEL HF120/60H POWERPLUSFeb 2, 2004
K000061MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNITApr 7, 2000
K973712MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNITDec 12, 1997
K945707MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNITJan 19, 1995
K911841MINXRAY P300 X-RAY SYSTEMAug 26, 1991
K854510MINXRAY 500M MAMMOGRAPHIC SYSTEMJan 1, 1986
K760741PORTABLE X-RAYOct 5, 1976

FDA data resources