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
1969–1992 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 15, 2022
XD
K220779 · LLZ
Mirada Medical, Ltd.
Radiology · 29d
Cleared Apr 15, 2022
RayStation 11B
K220141 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 87d
Cleared Apr 15, 2022
AI-Rad Companion Brain MR
K213706 · QIH
Siemens Healthcare GmbH
Radiology · 142d
Cleared Apr 14, 2022
TeleScan
K220767 · LLZ
Bb Imaging
Radiology · 29d
Cleared Apr 14, 2022
Yushan X-Ray Flat Panel Detector with DROC
K220510 · MQB
Innocare Optoelectronics Corp.
Radiology · 51d
Cleared Apr 13, 2022
OpenSensorX Series
K220556 · MUH
Dentimax, Inc.
Radiology · 44d
Cleared Apr 12, 2022
ThermPix Thermovisual Camera
K213650 · LHQ
Usa Therm, Inc.
Radiology · 144d
Cleared Apr 08, 2022
ImaCor Zura Handheld ZHH-010
K220490 · IYN
Imacor, Inc.
Radiology · 45d
Cleared Apr 08, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K220192 · LNH
Canon Medical Systems Corporation
Radiology · 74d
Cleared Apr 08, 2022
Breast BI Coil Set 0.55T
K220144 · MOS
Noras Mri Products GmbH
Radiology · 79d
Cleared Apr 08, 2022
INT Contour
K212274 · MUJ
Carina Medical, LLC
Radiology · 262d
Cleared Apr 06, 2022
ClariPulmo
K203783 · LLZ
Claripi, Inc.
Radiology · 464d
Cleared Apr 05, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction...
K220335 · LNH
Canon Medical Systems Corporation
Radiology · 57d
Cleared Apr 05, 2022
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
K220043 · IYN
Samsung Medison Co., Ltd.
Radiology · 90d
Cleared Apr 05, 2022
MRCAT Head & Neck
K214081 · MUJ
Philips OY
Radiology · 99d
Cleared Apr 04, 2022
ERI Handheld Dental X-ray System (Model AG100)
K213282 · EHD
Energy Resources International Co.,...
Radiology · 185d
Cleared Apr 04, 2022
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
K212624 · QIH
Ever Fortune.Ai, Co., Ltd.
Radiology · 229d
Cleared Apr 01, 2022
Wireless Digital Flat Panel Detector
K220668 · MQB
Iray Technology Taicang , Ltd.
Radiology · 25d
Cleared Apr 01, 2022
SKANRAD 400
K220518 · KPR
Skanray Technologies Limited
Radiology · 37d
Cleared Apr 01, 2022
MAGNETOM Avanto Fit
K220151 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Mar 31, 2022
APX-24 Portable X-ray System
K220678 · IZL
Aspenstate, Inc.
Radiology · 23d
Cleared Mar 30, 2022
VSP Bolus
K214093 · IXI
3D Systems
Radiology · 92d
Cleared Mar 30, 2022
VERIQA
K213370 · IYE
Ptw-Freiburg...
Radiology · 169d
Cleared Mar 30, 2022
Shield System
K212159 · OWB
Radiaction , Ltd.
Radiology · 261d