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
1993–2016 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 16, 2022
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
K213583 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 185d
Cleared May 16, 2022
Caas Qardia
K212376 · LLZ
Pie Medical Imaging BV
Radiology · 290d
Cleared May 16, 2022
SONON Ultrasound Imaging System, Model: SONON300C
K211665 · IYN
Healcerion Co., Ltd.
Radiology · 349d
Cleared May 13, 2022
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
K221144 · MQB
Radisen Co., Ltd.
Radiology · 23d
Cleared May 13, 2022
XACT ACE Robotic System
K221116 · JAK
Xact Robotics, Ltd.
Radiology · 28d
Cleared May 13, 2022
Quantib Prostate
K221106 · LLZ
Quantib B.V.
Radiology · 28d
Cleared May 13, 2022
MAGNETOM Skyra Fit
K220589 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared May 13, 2022
INTDose
K213137 · IYE
Carina Medical, LLC
Radiology · 228d
Cleared May 13, 2022
Spectral CT on Rails
K212875 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 246d
Cleared May 12, 2022
Saige-Dx
K220105 · QDQ
DeepHealth, Inc.
Radiology · 120d
Cleared May 11, 2022
Versana Balance
K220446 · IYN
GE Medical Systems Ultrasound and...
Radiology · 84d
Cleared May 11, 2022
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System),...
K212909 · IYE
Macromedics BV
Radiology · 240d
Cleared May 10, 2022
RadiForce MX243W
K221136 · PGY
Eizo Corporation
Radiology · 21d
Cleared May 10, 2022
inHEART MODELS
K220727 · LLZ
Inheart, Sas
Radiology · 57d
Cleared May 10, 2022
Overjet Caries Assist
K212519 · MYN
Overjet, Inc.
Radiology · 273d
Cleared May 06, 2022
NewTom 7G
K220664 · JAK
Cefla S.C.
Radiology · 60d
Cleared May 06, 2022
HM70 EVO Diagnostic Ultrasound System
K220269 · IYN
Samsung Medison Co., Ltd.
Radiology · 95d
Cleared May 06, 2022
KEOPS Balance Analyzer 3D
K213975 · LLZ
S.M.A.I.O
Radiology · 137d
Cleared May 06, 2022
Segment 3DPrint
K211966 · LLZ
Medviso AB
Radiology · 316d
Cleared May 05, 2022
17HQ901G-B
K220559 · MQB
Lg Electronics.Inc
Radiology · 66d
Cleared May 05, 2022
NAVIRFA Scope
K211529 · IYO
Navifus Corporation
Radiology · 353d
Cleared May 04, 2022
Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
K220700 · IZL
Yian Medical Technology (Haining)...
Radiology · 55d
Cleared May 04, 2022
Aurora-RT
K213526 · IYE
Magnettx Oncology Solutions , Ltd.
Radiology · 181d
Cleared May 03, 2022
Cardiovascular Angiography System
K220311 · OWB
Allengers Medical Systems Limited
Radiology · 90d