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
7921–7944 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 31, 2005
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)
K052775 · LLZ
Siemens AG Medical Solutions
Radiology · 28d
Cleared Oct 31, 2005
ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
K052911 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Oct 28, 2005
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
K052473 · IYX
Inter Medical Medizintechnik GmbH
Radiology · 49d
Cleared Oct 28, 2005
STARSPEED SERIES CT SCANNER SYSTEMS
K052855 · JAK
Ge Healthcare
Radiology · 17d
Cleared Oct 27, 2005
MINXRAY, MODEL HF100H+
K052721 · IZL
Minxray, Inc.
Radiology · 28d
Cleared Oct 27, 2005
FOURSIGHT VIEWTOOL IMAGE VIEWER
K052895 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Oct 26, 2005
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
K052884 · OWB
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Oct 24, 2005
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
K052361 · KPQ
Nucletron Corporation
Radiology · 56d
Cleared Oct 20, 2005
LUNAR IDXA
K052581 · KGI
Ge Medical Systems Ultrasound and...
Radiology · 30d
Cleared Oct 18, 2005
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
K052433 · MWP
Bioptics, Inc.
Radiology · 42d
Cleared Oct 17, 2005
REFORMAT GATEWAY
K052284 · LLZ
Infinitt Co., Ltd.
Radiology · 56d
Cleared Oct 17, 2005
HDR IORT SHIELDED APPLICATOR
K052351 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 49d
Cleared Oct 17, 2005
DAR-8000F
K052500 · IZI
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 17, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
K052571 · LNH
Neurognostics, Inc.
Radiology · 28d
Cleared Oct 17, 2005
MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
K052805 · IYN
Esaote, S.P.A.
Radiology · 13d
Cleared Oct 12, 2005
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
K052497 · MOS
Invivo Corp.
Radiology · 30d
Cleared Oct 07, 2005
WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
K052312 · LLZ
Wide Corporation
Radiology · 44d
Cleared Oct 07, 2005
AJEX 9015/135H PORTABLE X-RAY
K052341 · IZL
Jpi America, Inc.
Radiology · 42d
Cleared Oct 07, 2005
1.5T 12 CHANNEL BODY ARRAY
K052584 · MOS
Usa Instruments, Inc.
Radiology · 17d
Cleared Oct 07, 2005
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
K052621 · MOS
Usa Instruments, Inc.
Radiology · 14d
Cleared Oct 07, 2005
GEMINI RAPTOR
K052640 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 11d
Cleared Oct 05, 2005
ETIAM STAR PACS COMPONENTS
K052358 · LLZ
Etiam, S.A.
Radiology · 37d
Cleared Oct 04, 2005
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
K052164 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 56d
Cleared Oct 04, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K052430 · KPS
Digirad Corp.
Radiology · 28d