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
2017–2040 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
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