FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

47 results for "Canon Medical Systems USA, Inc."
25–47 of 47
Search insights Median review: 74d Cleared: 100% Top manufacturer: Canon Medical Systems Corporation Lead specialty: Radiology
Cleared May 17, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K211037 · LNH
Canon Medical Systems Corporation
Radiology · 40d
Cleared Apr 23, 2021
Cartesion Prime (PCD-1000A/3) V10.8
K203314 · KPS
Canon Medical Systems Corporation
Radiology · 164d
Cleared Apr 12, 2021
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
K210900 · OWB
Canon Medical Systems Corporation
Radiology · 17d
Cleared Apr 01, 2021
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit...
K210340 · LNH
Canon Medical Systems Corporation
Radiology · 55d
Cleared Mar 10, 2021
Vantage Elan 1.5T, MRT-2020, V6.0
K210164 · LNH
Canon Medical Systems Corporation
Radiology · 48d
Cleared Mar 04, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K203323 · LNH
Canon Medical Systems Corporation
Radiology · 112d
Cleared Feb 16, 2021
Vitrea Software Package, VSTP-001A
K203312 · LLZ
Canon Medical Systems Corporation
Radiology · 98d
Cleared Feb 02, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K203553 · LNH
Canon Medical Systems Corporation
Radiology · 60d
Cleared Jan 15, 2021
Vantage Orian 1.5T, MRT-1550, V6.0
K202767 · LNH
Canon Medical Systems Corporation
Radiology · 116d
Cleared Dec 18, 2020
Alphenix, INFX-8000V/B, /S, V9.1
K203551 · OWB
Canon Medical Systems Corporation
Radiology · 14d
Cleared Oct 16, 2020
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio...
K202737 · IYN
Canon Medical Systems Corporation
Radiology · 28d
Cleared Oct 15, 2020
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
K202364 · IYN
Canon Medical Systems Corporation
Radiology · 57d
Cleared Oct 08, 2020
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
K201972 · IYN
Canon Medical Systems Corporation
Radiology · 85d
Cleared Sep 18, 2019
Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
K191663 · IYN
Canon Medical Systems Corporation
Radiology · 89d
Cleared Jul 19, 2019
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
K191467 · IYN
Canon Medical Systems Corporation
Radiology · 46d
Cleared Jun 26, 2019
Vantage Titan 3T, MRT-3010, V2.5
K191128 · LNH
Canon Medical Systems Corporation
Radiology · 58d
Cleared Jun 12, 2019
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
K183046 · JAK
Canon Medical Systems Corporation
Radiology · 222d
Cleared Jun 05, 2019
Low Dose Lung Screening Option
K190505 · JAK
Canon Medical Systems Corporation
Radiology · 96d
Cleared Mar 15, 2019
Vantage Galan 3T, MRT-3020/A9, V5.0
K183657 · LNH
Canon Medical Systems Corporation
Radiology · 78d
Cleared Oct 19, 2018
Vantage Orian 1.5T, MRT-1550, V4.5
K182282 · LNH
Canon Medical Systems Corporation
Radiology · 57d
Cleared Oct 17, 2018
Alphenix, INFX-8000H/B, V8.0
K182546 · OWB
Canon Medical Systems Corporation
Radiology · 30d
Cleared Sep 28, 2018
Alphenix, INFX-8000F/B, V8.0
K182415 · OWB
Canon Medical Systems Corporation
Radiology · 24d
Cleared Aug 02, 2018
Alphenix, INFX-8000C/B, V8.0
K181804 · OWB
Canon Medical Systems Corporation
Radiology · 27d