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Analogic Corp.

FDA Regulatory Profile

Analogic Corp. has 0 FDA recalls, 7 inspections, 39 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 25, 2022 · NAI
Latest 510(k)
Feb 2, 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) clearances39Oct 4, 2026Not statedCurrent
Inspections7Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 25, 2022Peabody, MADevicesNo Action Indicated (NAI)1220672
Nov 4, 2019Peabody, MADevicesNo Action Indicated (NAI)1220672
May 17, 2017Peabody, MADevicesNo Action Indicated (NAI)1220672
Sep 4, 2014Peabody, MADevicesNo Action Indicated (NAI)1220672
Mar 23, 2012Peabody, MADevicesNo Action Indicated (NAI)1220672
Sep 19, 2011Peabody, MADevicesNo Action Indicated (NAI)1220672
Feb 16, 2010Peabody, MADevicesNo Action Indicated (NAI)1220672

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
K201231CTxx85 CT ScannerFeb 2, 2021
K182147CTXX85Sep 7, 2018
K172058CT6485, CT12885Feb 13, 2018
K161342Sonic WindowJun 15, 2016
K140126SONIC WINDOWMar 4, 2014
K071430SYNERAD OMNI, MODELS AN6255 AND AN6265Jun 21, 2007
K070829SYNEPIX 4600 DETECTORMay 9, 2007
K051903FETALGARD LITE-NIBP, MODEL FGL-NIBPDec 27, 2005
K052447SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600Sep 21, 2005
K050919LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P &…Jun 14, 2005
K043025SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250Nov 19, 2004
K041434C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORSAug 6, 2004
K041376C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL…Jul 20, 2004
K040995SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150May 25, 2004
K033345AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMSNov 19, 2003
K030931C3 PATIENT MONITORMay 9, 2003
K011304OB-1 FETAL MONITORMay 29, 2001
K002503FETALGARD LITENov 9, 2000
K001336DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEMJun 2, 2000
K001341DR5000 DEDICATED CHEST X-RAY SYSTEMJun 2, 2000

FDA data resources