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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
3193–3216 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 01, 2019
AI Rad Companion (Engine)
K183272 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Jan 31, 2019
Panoura X-ERA PF/NF/MF
K182198 · MUH
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 170d
Cleared Jan 29, 2019
X5 Series Digital Color Doppler Ultrasound System
K182648 · IYN
Sonoscape Medical Corp.
Radiology · 127d
Cleared Jan 28, 2019
Aloka Arietta 850
K183456 · IYN
Hitachi Healthcare Americas
Radiology · 46d
Cleared Jan 28, 2019
Venue GO
K183362 · IYN
GE Medical Systems Ultrasound and...
Radiology · 55d
Cleared Jan 24, 2019
ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
K183541 · KPR
Prognosys Medical Systems Private...
Radiology · 35d
Cleared Jan 24, 2019
MAGNETOM Lumina
K183244 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared Jan 24, 2019
E-CUBE i7
K182594 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 126d
Cleared Jan 22, 2019
O-Scan
K183685 · LNH
Esaote, S.P.A.
Radiology · 25d
Cleared Jan 22, 2019
HM70A Diagnostic Ultrasound System
K182894 · IYN
Samsung Medison Co., Ltd.
Radiology · 99d
Cleared Jan 18, 2019
Magnetom Vida
K183254 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Jan 18, 2019
SIGNA Premier
K183231 · LNH
Ge Medical Systems, LLC
Radiology · 59d
Cleared Jan 18, 2019
Pristina Serena 3D
K182951 · MUE
Ge Healthcare
Radiology · 87d
Cleared Jan 16, 2019
Carestream DRX-1 System with DRX Core Detectors
K183474 · MQB
Carestream Health, Inc.
Radiology · 30d
Cleared Jan 15, 2019
JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD...
K183497 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 29d
Cleared Jan 11, 2019
uMR 580, uMR 588
K183137 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared Jan 11, 2019
DigitalDiagnost C90
K182973 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 77d
Cleared Jan 11, 2019
MULTIX Impact
K182517 · KPR
Siemens Medi Cal Solutions, Inc.
Radiology · 120d
Cleared Jan 10, 2019
Trident HD Specimen Radiography System
K182727 · MWP
Hologic, Inc.
Radiology · 104d
Cleared Jan 10, 2019
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
K182636 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 108d
Cleared Jan 09, 2019
Wireless Digital Flat Detector
K183713 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Jan 09, 2019
Wireless Digital Flat Panel Detector
K183422 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Jan 09, 2019
MRCP+ v1.0
K183133 · LLZ
Perspectum Diagnostics, Ltd.
Radiology · 57d
Cleared Jan 09, 2019
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K181637 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 202d