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
5593–5616 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 19, 2012
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
K122173 · MQB
Rayence Co., Ltd.
Radiology · 88d
Cleared Oct 19, 2012
SDX SYSTEM
K121845 · IYE
Dyn'R Sas
Radiology · 116d
Cleared Oct 16, 2012
ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
K121564 · IYN
Olympus Medical Systems Corp.
Radiology · 140d
Cleared Oct 12, 2012
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6
K122574 · IYO
Edan Instruments, Inc.
Radiology · 50d
Cleared Oct 09, 2012
RADREX-I, SW V4.00 MODEL DRAD-3000E
K122842 · MQB
Toshiba America Medical Systems, In.C
Radiology · 22d
Cleared Oct 09, 2012
ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE
K121076 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 183d
Cleared Oct 05, 2012
C1-6-D ULTRASOUND TRANSDUCER
K122921 · ITX
Ge Healthcare
Radiology · 11d
Cleared Oct 05, 2012
MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
K122843 · LLZ
Prodigy Technology Consultant Co., Ltd.
Radiology · 18d
Cleared Oct 05, 2012
PORTA 100HF
K122697 · IZL
Job Corporation
Radiology · 31d
Cleared Oct 05, 2012
DFP4343C7
K122589 · KPR
Mdi Consultants, Inc.
Radiology · 42d
Cleared Oct 05, 2012
TBS INSIGHT
K121716 · KGI
Medimaps Group SA
Radiology · 116d
Cleared Oct 03, 2012
MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
K122450 · IYE
Mitsubishi Heavy Industries, Ltd.
Radiology · 51d
Cleared Oct 03, 2012
LOGIQ S7 EXPERT, LOGIQ S7 PRO
K122114 · IYN
Ge Healthcare
Radiology · 78d
Cleared Oct 03, 2012
AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER
K122009 · IYN
Panasonic Healthcare Co., Ltd.
Radiology · 86d
Cleared Sep 28, 2012
ACUSON
K122825 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Sep 28, 2012
EXACTRAC VERO
K122451 · IYE
Brainlab AG
Radiology · 46d
Cleared Sep 26, 2012
PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37
K122341 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 55d
Cleared Sep 26, 2012
ATHEROEDGE
K122022 · LLZ
Atheropoint, LLC
Radiology · 78d
Cleared Sep 26, 2012
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
K113483 · JAK
Philips Healthcare (Cleveland)
Radiology · 308d
Cleared Sep 25, 2012
TOSHIBA 3T 32CH HEAD SPEEDER COIL,
K122638 · MOS
Quality Electrodynamics
Radiology · 27d
Cleared Sep 25, 2012
FAXITRON SPECIEN RADIOGRAPHY SYSTEM
K122428 · MWP
Faxitron Bioptics, LLC
Radiology · 47d
Cleared Sep 21, 2012
VOLUSON E6/E8/E8EXPERT/E10
K122327 · IYN
Ge Healthcare
Radiology · 51d
Cleared Sep 21, 2012
AQUILION ONE VISION, V4.90
K122109 · JAK
Toshiba America Medical Systems, In.C
Radiology · 66d
Cleared Sep 21, 2012
PRISM ACQUIRE PRISM PROCESS PRISM VIEW
K122026 · LNH
Prism Clinical Imaging, Inc.
Radiology · 72d