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
2521–2544 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 20, 2020
DTX Studio Clinic
K203156 · LLZ
Nobel Biocare AB
Radiology · 29d
Cleared Nov 20, 2020
Optimized Positioning System (OPS) Insight
K202805 · LLZ
Corin USA
Radiology · 58d
Cleared Nov 20, 2020
Vscan Air
K202035 · ITX
GE Medical Systems Ultrasound and...
Radiology · 120d
Cleared Nov 20, 2020
MiniCAT 2D
K201825 · KPR
Xoran Technologies, LLC
Radiology · 141d
Cleared Nov 20, 2020
HALO
K200873 · QAS
Nico-Lab B.V.
Radiology · 233d
Cleared Nov 20, 2020
CorInsights MRI
K193287 · LLZ
Adm Diagnostics, Inc.
Radiology · 359d
Cleared Nov 18, 2020
DBSWIN, VISTAEASY
K203287 · LLZ
D?rr Dental SE
Radiology · 9d
Cleared Nov 18, 2020
HiRise
K203187 · JAK
Curvebeam, LLC
Radiology · 22d
Cleared Nov 18, 2020
TrueView 100 Pro
K202713 · MWP
Compai Healthcare (Shenzhen) Co.,Ltd
Radiology · 63d
Cleared Nov 18, 2020
Venue Go
K202233 · IYN
GE Medical Systems Ultrasound and...
Radiology · 103d
Cleared Nov 18, 2020
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy...
K201382 · OAS
De Gotzen S.R.L.
Radiology · 176d
Cleared Nov 18, 2020
syngo.via MI Workflows, syngo MBF
K201195 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 198d
Cleared Nov 18, 2020
Genius AI Detection
K201019 · QDQ
Hologic, Inc.
Radiology · 215d
Cleared Nov 17, 2020
PROView
K193306 · LLZ
GE Medical Systems SCS
Radiology · 354d
Cleared Nov 13, 2020
SIGNA Architect
K202966 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 44d
Cleared Nov 13, 2020
Venue
K202132 · IYN
GE Medical Systems Ultrasound and...
Radiology · 105d
Cleared Nov 12, 2020
ExacTrac Dynamic
K203173 · IYE
Brainlab AG
Radiology · 17d
Cleared Nov 12, 2020
Apache Ultrasound System (Model C62)
K202074 · IYN
Compal Electronics, Inc.
Radiology · 108d
Cleared Nov 12, 2020
FastStroke, CT Perfusion 4D
K193289 · JAK
GE Medical Systems SCS
Radiology · 351d
Cleared Nov 10, 2020
Nio Fusion 12MP (MDNC-12130)
K203106 · PGY
Barco N.V.
Radiology · 26d
Cleared Nov 09, 2020
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC...
K203128 · IYN
Olympus Medical Systems Corp.
Radiology · 21d
Cleared Nov 09, 2020
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound...
K201990 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 115d
Cleared Nov 06, 2020
Clio Prime and Clio Pedo
K202664 · MUH
Sota Precision Optics, Inc. Dba Sota...
Radiology · 53d
Cleared Nov 06, 2020
Neuro.Al Algorithm
K200750 · LLZ
Terarecon,Inc.
Radiology · 228d