Company ยท US
Analogic Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2021. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HGM | System, Monitoring, Perinatal | 7 |
| JAK | System, X-Ray, Tomography, Computed | 7 |
| KPR | System, X-Ray, Stationary | 7 |
| DPS | Electrocardiograph | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| LLZ | System, Image Processing, Radiological | 2 |
| DSB | Plethysmograph, Impedance | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 2, 2021 | K201231 | CTxx85 CT Scanner Analogic Corporation | JAK |
| Sep 7, 2018 | K182147 | CTXX85 Analogic Corporation | JAK |
| Feb 13, 2018 | K172058 | CT6485, CT12885 Analogic Corporation | JAK |
| Jun 15, 2016 | K161342 | Sonic Window Analogic Corporation | IYO |
| Mar 4, 2014 | K140126 | SONIC WINDOW Analogic Corporation | IYO |
| Jun 21, 2007 | K071430 | SYNERAD OMNI, MODELS AN6255 AND AN6265 Analogic Corp. | KPR |
| May 9, 2007 | K070829 | SYNEPIX 4600 DETECTOR Analogic Corporation | MQB |
| Dec 27, 2005 | K051903 | FETALGARD LITE-NIBP, MODEL FGL-NIBP Analogic Corporation | DXN |
| Sep 21, 2005 | K052447 | SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 Analogic Corp. | JAK |
| Jun 14, 2005 | K050919 | LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P Analogic Corp. | DSI |
| Nov 19, 2004 | K043025 | SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 Analogic Corp. | KPR |
| Aug 6, 2004 | K041434 | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS Analogic Corp. | DSB |
| Jul 20, 2004 | K041376 | C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A Analogic Corp. | MWI |
| May 25, 2004 | K040995 | SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 Analogic Corp. | KPR |
| Nov 19, 2003 | K033345 | AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS Analogic Corp. | KPR |
| May 9, 2003 | K030931 | C3 PATIENT MONITOR Analogic Corp. | MHX |
| May 29, 2001 | K011304 | OB-1 FETAL MONITOR Analogic Corp. | HGM |
| Nov 9, 2000 | K002503 | FETALGARD LITE Analogic Corp. | HGM |
| Jun 2, 2000 | K001341 | DR5000 DEDICATED CHEST X-RAY SYSTEM Analogic Corp. | KPR |
| Jun 2, 2000 | K001336 | DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM Analogic Corp. | KPR |
| Aug 12, 1999 | K983395 | FETALGARD 3000 FETAL MONITOR Analogic Corp. | HGM |
| Jul 2, 1999 | K991626 | WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION Analogic Corp. | LLZ |
| Aug 20, 1998 | K980411 | NPB3900 SERIES PATIENT MONITORS Analogic Corp. | MHX |
| Apr 2, 1998 | K980168 | COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE Analogic Corp. | LLZ |
| Feb 20, 1998 | K974455 | ANATOM 1000 (A MINUS, A-) Analogic Corp. | JAK |
| Mar 6, 1997 | K964890 | ANATOM 2000 Analogic Corp. | JAK |
| Dec 20, 1996 | K962424 | NPB-4000 Analogic Corp. | MHX |
| May 15, 1995 | K950420 | FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 Analogic Corp. | HGM |
| Jan 25, 1995 | K944131 | ANATOM 2000 Analogic Corp. | JAK |
| Oct 5, 1993 | K933103 | DIGITAL IMAGE COMMUNICATIONS SYSTEM Analogic Corp. | LMD |
| Jul 22, 1991 | K910169 | FETALGARD 2000 Analogic Corp. | HGM |
| Oct 16, 1986 | K860646 | PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART Analogic Corp. | DPS |
| Jul 15, 1986 | K855096 | SIEMENS SIRECUST MODELS 403P,403-2P & 403N Analogic Corp. | DPS |
| Apr 10, 1985 | K844791 | SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A Analogic Corp. | DSI |
| Mar 22, 1984 | K831319 | PATIENT MONITOR #404 Analogic Corp. | KLK |
| Mar 31, 1983 | K830029 | SIRECUST 400 Analogic Corp. | DSI |
| Jan 21, 1983 | K830028 | SIRECUST 456 Analogic Corp. | DXH |
| Oct 18, 1982 | K822091 | SIEMENS SIRECUST SYSTEM Analogic Corp. | |
| Jan 22, 1981 | K802113 | SIRECUST 400 SYSTEM PATIENT MONITORING Analogic Corp. | DPS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2005 | Analogic Corporation Analogic SyneRad Multi Digital Radiology System, Model AN6150 Terminated |
KPR | K040995 |
| Oct 12, 2005 | Analogic Corporation FETALGARD Lite Fetal Monitors, Model HCS
(Home Care Single Fetus Monitoring) Terminated |
HGM | None listed |
| Oct 12, 2005 | Analogic Corporation FETALGARD Lite Fetal Monitors, Model AP1S
(Single Fetus Monitoring) Terminated |
HGM | None listed |