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

44 results for "Canon Medical Systems, USA"
25–44 of 44
Search insights Median review: 120d Cleared: 100% Top manufacturer: Canon Medical Systems Corporation Lead specialty: Radiology
Cleared Dec 10, 2020
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
K203042 · JAK
Canon Medical Systems Corporation
Radiology · 65d
Cleared Dec 02, 2020
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit...
K203053 · LNH
Canon Medical Systems Corporation
Radiology · 56d
Cleared Oct 15, 2020
Cartesion Prime, PCD-1000A, V10.7
K202349 · KPS
Canon Medical Systems Corporation
Radiology · 58d
Cleared Sep 22, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
K202210 · LNH
Canon Medical Systems Corporation
Radiology · 47d
Cleared Jul 14, 2020
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit...
K193097 · LNH
Canon Medical Systems Corporation
Radiology · 250d
Cleared Jun 03, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
K193021 · LNH
Canon Medical Systems Corporation
Radiology · 217d
Cleared Mar 09, 2020
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K192574 · LNH
Canon Medical Systems Corporation
Radiology · 172d
Cleared Mar 02, 2020
Vantage Galan 3T, MRT-3020, V6.0
K192506 · LNH
Canon Medical Systems Corporation
Radiology · 172d
Cleared Feb 21, 2020
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
K192832 · JAK
Canon Medical Systems Corporation
Radiology · 142d
Cleared Feb 14, 2020
Vitrea Software Package
K192923 · LLZ
Canon Medical Systems Corporation
Radiology · 121d
Cleared Feb 13, 2020
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
K192828 · JAK
Canon Medical Systems Corporation
Radiology · 134d
Cleared Sep 06, 2019
Aquilion ONE (TSX-306A/3) V10.0
K192188 · JAK
Canon Medical Systems Corporation
Radiology · 24d
Cleared Aug 13, 2019
Cartesion Prime
K191582 · KPS
Canon Medical Systems Corporation
Radiology · 60d
Cleared Jul 23, 2019
Vantage Orian 1.5T, MRT-1550, V4.5
K191662 · LNH
Canon Medical Systems Corporation
Radiology · 32d
Cleared Dec 14, 2018
Vitrea Software Package, VSTP-001A
K182601 · LLZ
Canon Medical Systems Corporation
Radiology · 84d
Cleared Nov 26, 2018
Vitrea Software Package, VSTP-001A
K183013 · LLZ
Canon Medical Systems Corporation
Radiology · 26d
Cleared Sep 14, 2018
Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
K182223 · JAK
Canon Medical Systems, USA
Radiology · 29d
Cleared Sep 10, 2018
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
K181415 · OWB
Canon Medical Systems Corporation
Radiology · 103d
Cleared Jul 25, 2018
Alphenix, INFX-8000V/B, V8.0
K181670 · OWB
Canon Medical Systems Corporation
Radiology · 30d
Cleared Mar 30, 2018
Vitrea Software Package
K180323 · LLZ
Canon Medical Systems Corporation
Radiology · 53d