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
6649–6672 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 18, 2009
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
K090742 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 182d
Cleared Sep 15, 2009
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
K092134 · LLZ
Statrad, LLC
Radiology · 62d
Cleared Sep 15, 2009
MODEL 1014 PC ELECTROMETER
K092019 · IYE
Sun Nuclear Corp.
Radiology · 71d
Cleared Sep 15, 2009
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
K091117 · KXK
Isoaid, LLC
Radiology · 151d
Cleared Sep 09, 2009
NSM-S15 SYSTEM
K092237 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 48d
Cleared Sep 04, 2009
INREACH SYSTEM, MODEL AAS00161-02
K092365 · JAK
Superdimension, Ltd.
Radiology · 30d
Cleared Sep 02, 2009
CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE,...
K091877 · ITX
Chison Medical Imaging Co., Ltd.
Radiology · 71d
Cleared Sep 02, 2009
IMRX
K091166 · LNH
Imris, Inc.
Radiology · 133d
Cleared Aug 28, 2009
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED...
K092458 · KXK
Isoray Medical, Inc.
Radiology · 17d
Cleared Aug 28, 2009
PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90
K092285 · IYE
Best Medical Canada , Ltd.
Radiology · 30d
Cleared Aug 27, 2009
DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540
K092537 · MUH
Toshiba America Electronic...
Radiology · 8d
Cleared Aug 27, 2009
SYNGO.X
K092519 · LLZ
Siemens AG Medical Solutions
Radiology · 9d
Cleared Aug 27, 2009
MAMMOSITE MULTI LUMEN
K092405 · JAQ
Hologic, Inc.
Radiology · 21d
Cleared Aug 27, 2009
INSPIRA HD, MODEL: NL1000
K090811 · KPS
Neurologica Corporation
Radiology · 155d
Cleared Aug 25, 2009
IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR
K092307 · KPR
Imasight, Inc.
Radiology · 26d
Cleared Aug 25, 2009
NORDICBRAINEX SOFTWARE, VERSION 1.0
K092102 · LLZ
Nordicimaginglab AS
Radiology · 42d
Cleared Aug 25, 2009
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ,...
K092004 · OWB
Ge Healthcare
Radiology · 54d
Cleared Aug 25, 2009
HEAD FIXATION ARC AND TABLE BASE
K091439 · HBL
Surgivision, Inc.
Radiology · 103d
Cleared Aug 21, 2009
GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND
K092140 · IYO
Ge Medical Systems Israel,...
Radiology · 37d
Cleared Aug 21, 2009
1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL...
K091902 · MOS
Invivo
Radiology · 57d
Cleared Aug 21, 2009
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
K091628 · IXW
Protec GmbH & Co. KG
Radiology · 78d
Cleared Aug 19, 2009
CONTURA CAVITY MAINTENANCE CATHETER
K092323 · JAQ
Senorx, Inc.
Radiology · 15d
Cleared Aug 14, 2009
MEDI-6000 MEDICAL IMAGE DIGITIZER
K091288 · LMA
Microtek International, Inc.
Radiology · 105d
Cleared Aug 12, 2009
AIXPLORER ULTRASOUND SYSTEM
K091970 · IYN
Supersonic Imagine
Radiology · 42d