Analogic Corp.

Peabody, MA, US

Analogic Corp. appears in FDA device records in Peabody, MA. FDA records list 39 510(k) clearances between 1981-01-22 and 2021-02-02, no PMA records and no registered establishments. As of 2026-09-10, FDA records show 3 recalls for this company.

510(k) clearances: 39
PMA records: 0
Recall records: 3
Registered establishments: 0

510(k) clearance history

FDA records hold 39 510(k) clearances for Analogic Corp. between 1981 and 2021. The busiest year on record is 2004, with 4. The most recent is 2021, with 1.

Clearances by year, as a table

510(k) clearance decisions for Analogic Corp., by decision year
Year	Clearances
1981	1
1982	1
1983	2
1984	1
1985	1
1986	2
1991	1
1993	1
1995	2
1996	1
1997	1
1998	3
1999	2
2000	3
2001	1
2003	2
2004	4
2005	3
2007	2
2014	1
2016	1
2018	2
2021	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K201231	CTxx85 CT Scanner	JAK	Substantially Equivalent	2021-02-02
K182147	CTXX85	JAK	Substantially Equivalent	2018-09-07
K172058	CT6485, CT12885	JAK	Substantially Equivalent	2018-02-13
K161342	Sonic Window	IYO	Substantially Equivalent	2016-06-15
K140126	SONIC WINDOW	IYO	Substantially Equivalent	2014-03-04
K071430	SYNERAD OMNI, MODELS AN6255 AND AN6265	KPR	Substantially Equivalent	2007-06-21
K070829	SYNEPIX 4600 DETECTOR	MQB	Substantially Equivalent	2007-05-09
K051903	FETALGARD LITE-NIBP, MODEL FGL-NIBP	DXN	Substantially Equivalent	2005-12-27
K052447	SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600	JAK	Substantially Equivalent	2005-09-21
K050919	LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P	DSI	Substantially Equivalent	2005-06-14
K043025	SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250	KPR	Substantially Equivalent	2004-11-19
K041434	C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS	DSB	Substantially Equivalent	2004-08-06
K041376	C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A	MWI	Substantially Equivalent	2004-07-20
K040995	SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150	KPR	Substantially Equivalent	2004-05-25
K033345	AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS	KPR	Substantially Equivalent	2003-11-19
K030931	C3 PATIENT MONITOR	MHX	Substantially Equivalent	2003-05-09
K011304	OB-1 FETAL MONITOR	HGM	Substantially Equivalent	2001-05-29
K002503	FETALGARD LITE	HGM	Substantially Equivalent	2000-11-09
K001341	DR5000 DEDICATED CHEST X-RAY SYSTEM	KPR	Substantially Equivalent	2000-06-02
K001336	DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM	KPR	Substantially Equivalent	2000-06-02
K983395	FETALGARD 3000 FETAL MONITOR	HGM	Substantially Equivalent	1999-08-12
K991626	WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION	LLZ	Substantially Equivalent	1999-07-02
K980411	NPB3900 SERIES PATIENT MONITORS	MHX	Substantially Equivalent	1998-08-20
K980168	COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE	LLZ	Substantially Equivalent	1998-04-02
K974455	ANATOM 1000 (A MINUS, A-)	JAK	Substantially Equivalent	1998-02-20
K964890	ANATOM 2000	JAK	Substantially Equivalent	1997-03-06
K962424	NPB-4000	MHX	Substantially Equivalent	1996-12-20
K950420	FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3	HGM	Substantially Equivalent	1995-05-15
K944131	ANATOM 2000	JAK	Substantially Equivalent	1995-01-25
K933103	DIGITAL IMAGE COMMUNICATIONS SYSTEM	LMD	Substantially Equivalent	1993-10-05
K910169	FETALGARD 2000	HGM	Substantially Equivalent	1991-07-22
K860646	PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART	DPS	Substantially Equivalent	1986-10-16
K855096	SIEMENS SIRECUST MODELS 403P,403-2P & 403N	DPS	Substantially Equivalent	1986-07-15
K844791	SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A	DSI	Substantially Equivalent	1985-04-10
K831319	PATIENT MONITOR #404	KLK	Substantially Equivalent	1984-03-22
K830029	SIRECUST 400	DSI	Substantially Equivalent	1983-03-31
K830028	SIRECUST 456	DXH	Substantially Equivalent	1983-01-21
K822091	SIEMENS SIRECUST SYSTEM		Substantially Equivalent	1982-10-18
K802113	SIRECUST 400 SYSTEM PATIENT MONITORING	DPS	Substantially Equivalent	1981-01-22

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Initiated	Status
Z-0196-06	Analogic SyneRad Multi Digital Radiology System, Model AN6150	Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possiible injury of the user or patient.	2005-10-14	Terminated
Z-0036-06	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)	Unit may not power up due to faulty circuit board	2005-09-13	Terminated
Z-0035-06	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)	Unit may not power up due to faulty circuit board	2005-09-13	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain