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
3337–3360 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 23, 2018
JiveX
K181964 · LLZ
Visus Health IT GmbH
Radiology · 92d
Cleared Oct 22, 2018
GM Implant Tubes, Length Cutting Gauge
K172533 · JAQ
Varian Medical Systems, Inc.
Radiology · 426d
Cleared Oct 19, 2018
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
K182590 · MOS
Ge Healthcare
Radiology · 29d
Cleared Oct 19, 2018
UroNav (Version 3.0)
K182561 · LLZ
Invivo Corporation
Radiology · 31d
Cleared Oct 19, 2018
Vivid S60N, Vivid S70N
K182450 · IYN
GE Medical Systems Ultrasound and...
Radiology · 42d
Cleared Oct 19, 2018
Vantage Orian 1.5T, MRT-1550, V4.5
K182282 · LNH
Canon Medical Systems Corporation
Radiology · 57d
Cleared Oct 19, 2018
MAGNETOM Vida
K181433 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Oct 19, 2018
EchoS
K180516 · MUA
Echolight S.P.A
Radiology · 234d
Cleared Oct 18, 2018
RadiForce RX360, RX360-AR
K182591 · PGY
Eizo Corporation
Radiology · 28d
Cleared Oct 18, 2018
14HK701G-W
K182348 · MQB
Lg Electronics.Inc
Radiology · 50d
Cleared Oct 17, 2018
Wireless Digital Flat Panel Detector
K182551 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Oct 17, 2018
Wireless Digital Flat Panel Detector
K182550 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Oct 17, 2018
Alphenix, INFX-8000H/B, V8.0
K182546 · OWB
Canon Medical Systems Corporation
Radiology · 30d
Cleared Oct 17, 2018
Arterys MICA
K182034 · LLZ
Arterys, Inc.
Radiology · 79d
Cleared Oct 16, 2018
RCT700
K182614 · OAS
Ray Co., Ltd.
Radiology · 25d
Cleared Oct 12, 2018
3.0T Air MP M, 3.0T Air MP L
K182504 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 30d
Cleared Oct 12, 2018
uMI 550 PET/CT System
K182237 · KPS
Shanghai United Imaging Healthcare...
Radiology · 56d
Cleared Oct 12, 2018
MAGNETOM Sola
K182129 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Oct 11, 2018
E-CUBE 8
K181617 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 114d
Cleared Oct 11, 2018
OnePacs System
K181460 · LLZ
Onepacs, LLC
Radiology · 129d
Cleared Oct 09, 2018
Ziostation2
K181892 · LLZ
Ziosoft, Inc.
Radiology · 88d
Cleared Oct 05, 2018
MAGNETOM Sola
K181322 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Oct 04, 2018
PIXX 1717
K182533 · MQB
Pixxgen Corporation
Radiology · 20d
Cleared Oct 04, 2018
Encompass SRS Headframe
K182189 · IYE
Qfix
Radiology · 52d