FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
1921–1944 of 15,589
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