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
1897–1920 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 03, 2022
Transpara 1.7.2
K221347 · QDQ
Screenpoint Medical B.V.
Radiology · 86d
Cleared Aug 01, 2022
X-ray Flat Panel Detectors (CareView 1800 RF)
K221549 · MQB
Careray Digital Medical Technology...
Radiology · 62d
Cleared Jul 29, 2022
Deep Learning Image Reconstruction
K220961 · JAK
Ge Healthcare Japan Corporation
Radiology · 119d
Cleared Jul 29, 2022
ABMD Software
K213760 · KGI
HeartLung Corporation
Radiology · 240d
Cleared Jul 28, 2022
Swoop Portable MR Imaging System
K221923 · LNH
Hyperfine, Inc.
Radiology · 27d
Cleared Jul 28, 2022
Trinias
K221922 · OWB
Shimadzu Corporation Medical Systems...
Radiology · 27d
Cleared Jul 28, 2022
TRON
K221230 · OWB
Xoran Technologies, LLC
Radiology · 90d
Cleared Jul 28, 2022
cvi42 Auto Imaging Software Application
K213998 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 219d
Cleared Jul 27, 2022
OTC DDR
K221853 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 30d
Cleared Jul 26, 2022
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
K221567 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 56d
Cleared Jul 25, 2022
Viz SDH
K220439 · QAS
Viz. Ai, Inc.
Radiology · 159d
Cleared Jul 22, 2022
PreXion3D Explorer PRO
K221525 · OAS
Prexion Corporation
Radiology · 57d
Cleared Jul 22, 2022
10HQ701G-B
K221461 · MQB
Lg Electronics.Inc
Radiology · 64d
Cleared Jul 22, 2022
14HQ701G-B
K221394 · MQB
Lg Electronics.Inc
Radiology · 70d
Cleared Jul 22, 2022
EchoPAC Software Only, EchoPAC Plug-in
K220940 · QIH
GE Medical Systems Ultrasound and...
Radiology · 113d
Cleared Jul 22, 2022
Vivid E80, Vivid E90, Vivid E95
K220882 · IYN
Ge Medical Systems Ultrasound And
Radiology · 119d
Cleared Jul 22, 2022
AI4CMR v1.0
K220624 · LLZ
Ai4medimaging Medical Solutions S.A.
Radiology · 141d
Cleared Jul 22, 2022
FX SPS
K213922 · LLZ
Pixee Medical
Radiology · 219d
Cleared Jul 20, 2022
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
K221512 · MQB
Vieworks Co., Ltd.
Radiology · 57d
Cleared Jul 20, 2022
Libby Echo:Prio
K220956 · QIH
Dyad Medical, Inc.
Radiology · 110d
Cleared Jul 20, 2022
AutoSeg
K220039 · LLZ
Ai Medic, Inc.
Radiology · 196d
Cleared Jul 19, 2022
ARTIS icono (Ceiling Configuration)
K221516 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jul 19, 2022
BrainInsight
K220815 · QIH
Hyperfine, Inc.
Radiology · 120d
Cleared Jul 18, 2022
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
K221803 · IZL
Sedecal., Sa.
Radiology · 26d