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 × Cleared only ×
15,676 results
2041–2064 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Mar 29, 2022
Focus HD 35 Detector
K213646 · MQB
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Mar 29, 2022
Focus HD 43 Detector
K213529 · MQB
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Mar 28, 2022
Syngo.CT Dual Energy
K212889 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared Mar 25, 2022
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10...
K220242 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 56d
Cleared Mar 25, 2022
DTX Studio Clinic 3.0
K213562 · LLZ
Nobel Biocare AB
Radiology · 136d
Cleared Mar 25, 2022
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210...
K212231 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 252d
Cleared Mar 23, 2022
DRX-Rise Mobile X-ray System
K213568 · IZL
Carestream Health
Radiology · 134d