Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology ×
15,695 results
2041–2064 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 19, 2022
General Radiography X-ray System (Model: GR10X 40K), General Radiography...
K220149 · KPR
Xera Medical Systems & Technology , Ltd.
Radiology · 90d
Cleared Apr 18, 2022
Nautilus
K220871 · JAA
Dornier Medtech America, Inc.
Radiology · 24d
Cleared Apr 15, 2022
SURGIVISIO Device
K220946 · OWB
Ecential Robotics
Radiology · 14d
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