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
8161–8184 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 03, 2005
SYNGO INSPACE 4D
K043469 · JAK
Siemens AG Medical Solutions
Radiology · 49d
Cleared Feb 02, 2005
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · KXK
C.R. Bard, Inc.
Radiology · 71d
Cleared Feb 02, 2005
GE LOGIQ TWIN
K050126 · IYN
General Electric Co.
Radiology · 14d
Cleared Jan 31, 2005
BEAM MODULATOR, MODEL 4513 332 8000
K042794 · IYE
Elekta , Ltd.
Radiology · 116d
Cleared Jan 31, 2005
IN EXAM INTRAORAL DENTAL X-RAY SYSTEM
K050019 · EHD
Kavo America
Radiology · 26d
Cleared Jan 31, 2005
R605 FACS COLLIMETER
K050092 · IZW
Omega Medical Imaging, Inc.
Radiology · 17d
Cleared Jan 28, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
K043290 · LNH
Neurognostics, Inc.
Radiology · 60d
Cleared Jan 28, 2005
20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB
K043430 · LLZ
Totoku Electric Co., Ltd.
Radiology · 46d
Cleared Jan 28, 2005
RADIN, MODEL V 3.0
K043483 · LLZ
Sohard AG
Radiology · 42d
Cleared Jan 28, 2005
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
K050099 · IYN
Kontron Medical Systems Sas
Radiology · 10d
Cleared Jan 26, 2005
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
K043596 · KXK
Theragenics Corp.
Radiology · 28d
Cleared Jan 25, 2005
MYLAB 15 / MYLAB 20, MODEL 2700
K043588 · IYN
Pie Medical
Radiology · 28d
Cleared Jan 21, 2005
R2-MRI ANALYSIS SYSTEM
K043271 · LNH
Inner Vision Biometrics Pty, Ltd.
Radiology · 56d
Cleared Jan 21, 2005
OPTISTRAND, MODEL 1032S
K043336 · KXK
Ibt SA
Radiology · 49d
Cleared Jan 21, 2005
CENTRICITY PACS SYSTEM
K043415 · LLZ
Ge Medical Systems Information...
Radiology · 39d
Cleared Jan 19, 2005
SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
K042961 · IZI
Novadaq Technologies, Inc.
Radiology · 84d
Cleared Jan 14, 2005
ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
K043554 · IYN
B & K Medical A/S
Radiology · 18d
Cleared Jan 13, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
K042602 · MQB
Ge Medical Systems, LLC
Radiology · 111d
Cleared Jan 13, 2005
MIRAGE, RELEASE 5.5
K043441 · KPS
Segami Corporation
Radiology · 30d
Cleared Jan 13, 2005
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
K043524 · IYN
B & K Medical A/S
Radiology · 24d
Cleared Jan 13, 2005
MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
K043557 · EHD
Panoramic Corp.
Radiology · 17d
Cleared Jan 13, 2005
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K050034 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 6d
Cleared Jan 12, 2005
ODYSSEY
K042861 · MUJ
Permedics, Inc.
Radiology · 89d
Cleared Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262 · LNH
Ge Healthcare
Radiology · 49d