FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
1825–1848 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 18, 2022
Vivid iq
K221148 · IYN
GE Medical Systems Ultrasound &...
Radiology · 89d
Cleared Jul 18, 2022
Vivid T8, Vivid T9
K221147 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Jul 18, 2022
Planmed Clarity 2D, Planmed Clarify S
K211720 · MUE
Planmed OY
Radiology · 409d