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
6289–6312 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 12, 2011
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM
K103144 · IYN
Shantou Institute of Ultrasonic...
Radiology · 79d
Cleared Jan 12, 2011
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
K102915 · MUJ
Viewray, Incorporated
Radiology · 103d
Cleared Jan 11, 2011
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
K103275 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Jan 07, 2011
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512 · IZH
Hologic, Inc.
Radiology · 38d
Cleared Jan 07, 2011
6250 ULTRASOUND SYTEMS
K103152 · IYN
Esaote, S.P.A.
Radiology · 73d
Cleared Jan 06, 2011
THE ADDITION
K102683 · MUI
Ob The-Addition, LLC
Radiology · 111d
Cleared Jan 05, 2011
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
K103722 · ITX
Medison Co., Ltd.
Radiology · 15d
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