FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
4537–4560 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 02, 2015
OrthoVis Web Portal
K151501 · LLZ
Custom Orthopaedic Solutions, Inc.
Radiology · 120d
Cleared Sep 30, 2015
MultiScan G-Arm System
K151280 · OXO
Beijing East Whale Imaging Technology...
Radiology · 139d
Cleared Sep 30, 2015
Supria Whole-body X-ray CT System
K150565 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 208d
Cleared Sep 29, 2015
LOGIQ S8
K152195 · IYN
Ge Healthcare
Radiology · 55d
Cleared Sep 29, 2015
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM...
K151579 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Sep 28, 2015
Onrad Treatment System
K152488 · MUJ
Accuray Incorporated
Radiology · 28d
Cleared Sep 22, 2015
Permanent Sled Bag
K152403 · ITX
Boston Scientific
Radiology · 28d
Cleared Sep 21, 2015
ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System
K152469 · IYN
Siemens Medical Solutions, Inc.,...
Radiology · 21d
Cleared Sep 21, 2015
CARESTREAM Vue Motion
K151774 · LLZ
Carestream Health, Inc.
Radiology · 82d
Cleared Sep 18, 2015
Eclipse Treatment Planning System
K152393 · MUJ
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Sep 18, 2015
iLab Ultrasound Imaging System
K152316 · IYO
Boston Scientific
Radiology · 32d
Cleared Sep 16, 2015
Ultrasound Scanner System bk2300
K152052 · IYN
Bk Medical Aps
Radiology · 55d
Cleared Sep 16, 2015
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
K152030 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 56d
Cleared Sep 16, 2015
syngo VSim
K151887 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 68d
Cleared Sep 16, 2015
Radio Therapy Treatment Chair
K150382 · IYE
Radiation Products Design, Inc.
Radiology · 210d
Cleared Sep 14, 2015
LOGIQ E9, LOGIQ E9 XDClear 2.0
K152309 · IYN
GE Medical Systems Ultrasound and...
Radiology · 31d
Cleared Sep 14, 2015
MAMMOMAT Fusion
K151645 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Sep 11, 2015
CT Sim Laser System
K152303 · IWE
Gammex, Inc.
Radiology · 28d
Cleared Sep 11, 2015
Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel...
K152018 · JAQ
Varian Medical Systems, Inc.
Radiology · 52d
Cleared Sep 11, 2015
QuickPlan
K151560 · MUJ
Siris Medical
Radiology · 93d
Cleared Sep 10, 2015
ViZion DR + Wireless
K152279 · MQB
Viztek, LLC
Radiology · 29d
Cleared Sep 10, 2015
JUSHA-C43 LCD Monitor
K151972 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 56d
Cleared Sep 10, 2015
JUSHA-C23C LCD Monitor
K151861 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 64d
Cleared Sep 10, 2015
SONON Ultrasound Imaging System (Model: SONON 300C)
K151339 · IYO
Healcerion Co., Ltd.
Radiology · 114d