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
2017–2040 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Apr 29, 2022
Bindex BI-2
K211350 · MUA
Bone Index Finland , Ltd.
Radiology · 361d
Cleared Apr 28, 2022
Digital flat panel detector
K220536 · MQB
Iray Technology Taicang , Ltd.
Radiology · 63d
Cleared Apr 28, 2022
EFAI RTSuite CT HN-Segmentation System
K220264 · QKB
Ever Fortune.Ai, Co., Ltd.
Radiology · 87d
Cleared Apr 28, 2022
Planmed Verity
K213278 · OAS
Planmed OY
Radiology · 209d
Cleared Apr 28, 2022
AngioCloud Service
K211713 · LLZ
Angiocloud, LLC
Radiology · 329d
Cleared Apr 27, 2022
Philips Incisive CT
K212441 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 266d
Cleared Apr 26, 2022
BriefCase
K213886 · QAS
Aidoc Medical , Ltd.
Radiology · 134d
Cleared Apr 22, 2022
HYBRID S70
K220574 · EHD
Digimed Co., Ltd.
Radiology · 53d
Cleared Apr 22, 2022
HealthOST
K213944 · JAK
Nanoxai , Ltd.
Radiology · 126d
Cleared Apr 22, 2022
ATUSA™ Automated 3D Breast Ultrasound System
K213620 · IYO
Isono Health, Inc.
Radiology · 157d
Cleared Apr 22, 2022
MirrorMe3D Modeling System
K212981 · LLZ
Mirrorme3D, LLC
Radiology · 217d
Cleared Apr 22, 2022
SONON Ultrasound Imaging System, Model: SONON 500L
K212400 · IYN
Healcerion Co., Ltd.
Radiology · 263d
Cleared Apr 21, 2022
GM85
K220175 · IZL
Samsung Electronics Co., Ltd.
Radiology · 90d
Cleared Apr 21, 2022
Videa Caries Assist
K213795 · MYN
Videahealth, Inc.
Radiology · 136d