Medical Device Manufacturer · US , Mchenry , IL

Analogic Corp. - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 1981

Recent clearances: SYNERAD OMNI, MODELS AN6255 AND AN6265, SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600, LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P

Total

Cleared

Denied

Analogic Corp. is an American multinational corporation specializing in healthcare technology and aviation security. The company, based in McHenry, US, primarily produces imaging equipment including CT scan, digital mammography, and MRI systems for health facilities.

Analogic has received 32 FDA 510(k) clearances from 32 total submissions since its first clearance in 1981. The company's regulatory record reflects a strong focus on radiology devices and cardiovascular monitoring systems. The latest FDA 510(k) clearance dates to 2007, establishing this as a historical regulatory record.

Cleared device categories include digital X-ray systems, patient monitors, impedance cardiography monitors, and fetal monitoring equipment. Notable product lines include the SYNERAD series for radiology and the LIFEGARD family for cardiovascular monitoring.

Explore the complete list of device names, product codes, and clearance dates in the database records below.

510(k) submissions have been managed by Intertek Testing Services as regulatory consultant.

Analogic Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.