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
1993–2016 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared May 03, 2022
exoplan
K213302 · LLZ
Exocad GmbH
Radiology · 211d
Cleared May 03, 2022
MVision AI Segmentation
K212915 · QKB
MVision AI
Radiology · 232d
Cleared May 02, 2022
Liver Suite
K211180 · JAK
GE Medical Systems SCS
Radiology · 377d
Cleared Apr 29, 2022
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
K220939 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Apr 29, 2022
Oryx Cloud Imaging
K220684 · LLZ
Oryx Dental Software, Inc.
Radiology · 52d
Cleared Apr 29, 2022
aPROMISE X
K220590 · LLZ
Exini Diagnostics AB
Radiology · 59d
Cleared Apr 29, 2022
ExacTrac Dynamic
K220338 · IYE
Brainlab AG
Radiology · 81d
Cleared Apr 29, 2022
ARIETTA 50
K220295 · IYN
Fujifilm Healthcare Corporation
Radiology · 86d
Cleared Apr 29, 2022
Hand Diagnostic Radiography Imaging System
K220271 · KPR
Nanoray Biotech Co., Ltd.
Radiology · 88d
Cleared Apr 29, 2022
BodyTom 64
K213649 · JAK
Neurologica Corporation
Radiology · 161d