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
6961–6984 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 08, 2008
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
K082761 · JAK
Ge Medical Systems, LLC
Radiology · 16d
Cleared Oct 08, 2008
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
K082816 · JAK
Ge Medical Systems, LLC
Radiology · 13d
Cleared Oct 07, 2008
STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100
K081935 · IYE
Aktina Medical Physics Corp.
Radiology · 92d
Cleared Oct 06, 2008
COLOR LCD MONITOR
K082663 · LLZ
Eizo Nanao Corporation
Radiology · 24d
Cleared Oct 01, 2008
MAGNETOM C!
K082331 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Oct 01, 2008
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS...
K082510 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 33d
Cleared Sep 30, 2008
CIVASTRING PD-103
K082159 · KXK
Civatech Oncology, Inc.
Radiology · 61d
Cleared Sep 30, 2008
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
K082656 · IYN
Fukuda Denshi USA, Inc.
Radiology · 18d
Cleared Sep 26, 2008
UNISYN IMAGE FUSION, VERSION 1.0
K081987 · LLZ
Convergent Imaging Solutions
Radiology · 74d
Cleared Sep 26, 2008
PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX
K082167 · EHD
Digimed Corporation
Radiology · 57d
Cleared Sep 26, 2008
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317 · KGI
General Electric Co.
Radiology · 44d
Cleared Sep 25, 2008
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
K081386 · IYN
Esaote, S.P.A.
Radiology · 129d
Cleared Sep 25, 2008
AW SERVER
K081985 · LLZ
Ge Medical Systems, LLC
Radiology · 73d
Cleared Sep 25, 2008
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
K082636 · MOS
Quality Electrodynamics
Radiology · 15d
Cleared Sep 23, 2008
ULTRAEXTEND USWS-900A
K082596 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Sep 22, 2008
PLANISIGHT LINASYS
K082228 · LLZ
Pathfinder Therapeutics, Inc.
Radiology · 46d
Cleared Sep 19, 2008
RAYPAX SYSTEM
K081948 · LLZ
Raypax, Inc.
Radiology · 73d
Cleared Sep 17, 2008
SPY ANALYSIS TOOLKIT, MODEL SA9000
K081792 · LLZ
Novadaq Technologies, Inc.
Radiology · 84d
Cleared Sep 16, 2008
MODIFICATION TO AURORA MRI SYSTEM
K073425 · LNH
Aurora Imaging Technology, Inc.
Radiology · 288d
Cleared Sep 16, 2008
INREACH PLANNING LAPTOP
K082386 · LLZ
Superdimension, Ltd.
Radiology · 28d
Cleared Sep 12, 2008
21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)
K081945 · LLZ
Totoku Electric Co., Ltd.
Radiology · 66d
Cleared Sep 12, 2008
CONTURA LUMEN MARKER
K082264 · JAQ
Senorx, Inc.
Radiology · 32d
Cleared Sep 12, 2008
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT...
K082368 · KPS
Digirad Corp.
Radiology · 25d
Cleared Sep 12, 2008
QUANTRA
K082483 · LLZ
Hologic, Inc.
Radiology · 15d