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
6265–6288 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 05, 2011
SPINEANALYER MODEL SAPOC
K103475 · LLZ
Optasia Medical
Radiology · 42d
Cleared Jan 03, 2011
DX-D 100
K103597 · IZL
Agfa Healthcare N.V.
Radiology · 26d
Cleared Jan 03, 2011
I-SEED
K103319 · KXK
Theragenics Corp.
Radiology · 52d
Cleared Jan 03, 2011
1.5T 16-CHANNEL HAND-WRIST COIL
K103149 · MOS
Invivo Corporation
Radiology · 70d
Cleared Jan 03, 2011
KRYSTALRAD (ATAL8)
K102285 · KPR
Medicatech USA
Radiology · 144d
Cleared Jan 03, 2011
KRYSTALRAD 560 (FLAATZ 560)
K102284 · KPR
Medicatech USA
Radiology · 144d
Cleared Dec 27, 2010
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
K103608 · IYO
Ellex, Inc.
Radiology · 18d
Cleared Dec 27, 2010
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K103583 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 20d
Cleared Dec 27, 2010
DOSEVIEW 3D
K103193 · IYE
Standard Imaging, Inc.
Radiology · 59d
Cleared Dec 27, 2010
MEDISTIM VERIQC SYSTEM
K102595 · DPW
Medi-Stim Asa
Radiology · 109d
Cleared Dec 27, 2010
DIGITAL DIAGNOSTIC X-RAY SYSTEM
K102408 · KPR
DRGEM Corporation
Radiology · 126d
Cleared Dec 27, 2010
PT2 VARIAN PROTON THERAPY SYSTEM
K101294 · LHN
Varian Medical Systems, Oncology Systems
Radiology · 231d
Cleared Dec 23, 2010
3.0T METAFLEXCOIL
K103342 · MOS
Neocoil, LLC
Radiology · 38d
Cleared Dec 22, 2010
31P/1H DUAL TUNED SURFACE COIL 3T
K102348 · MOS
Rapid Biomedical GmbH
Radiology · 125d
Cleared Dec 22, 2010
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
K102027 · IYO
Quantel Medical S.A.
Radiology · 156d
Cleared Dec 21, 2010
LEKSELL GAMMAPLAN
K103093 · MUJ
Elekta Instrument AB
Radiology · 63d
Cleared Dec 21, 2010
SONIXTABLET ULTRASOUND SCANNER
K102997 · IYN
Ultrasonix Medical Corporation
Radiology · 75d
Cleared Dec 21, 2010
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
K100703 · MQB
Comed Co., Ltd.
Radiology · 284d
Cleared Dec 20, 2010
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
K102889 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Dec 14, 2010
SAFECT MODEL VER 1.0
K100372 · LLZ
Medic Vision Brain Technologies, Ltd.
Radiology · 305d
Cleared Dec 09, 2010
OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
K102989 · IYN
Chang Gung Medical Technology Co.,...
Radiology · 64d
Cleared Dec 07, 2010
PRONEX
K102765 · IYE
Direx Systems Corp.
Radiology · 74d
Cleared Dec 03, 2010
PACENTRIC CONNECT, TRAVELER AND WEB
K100837 · LLZ
Fimreite Software AS
Radiology · 254d
Cleared Dec 03, 2010
STELLATE GRIDVIEW
K100126 · OLX
Excel-Tech Ltd. (Xltek)
Radiology · 318d