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
5881–5904 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 16, 2012
SURFACE BEACON TRANSPONDERS
K112841 · IYE
Calypso Medical Technologies, Inc.
Radiology · 140d
Cleared Feb 14, 2012
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
K113403 · OWB
GE Medical Systems SCS
Radiology · 89d
Cleared Feb 14, 2012
CADENS (TM) COLON
K111758 · LLZ
Dog Microsystems, Inc.
Radiology · 237d
Cleared Feb 10, 2012
REGIUS SIGMA2
K120131 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 24d
Cleared Feb 10, 2012
SENSE MSK S 8CH 1.5T
K120122 · MOS
Invivo Corporation
Radiology · 24d
Cleared Feb 10, 2012
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
K113612 · IYN
Panasonic Healthcare Co., Ltd.
Radiology · 66d
Cleared Feb 10, 2012
NOTOUCH BREASTSCAN
K113259 · LHQ
Ue Lifesciences, Inc.
Radiology · 98d
Cleared Feb 08, 2012
PUREIMAGE ULTRASOUND TRANSMISSION GEL
K120156 · ITX
Medline
Radiology · 21d
Cleared Feb 08, 2012
EPIGRAY
K112723 · MUJ
Dosisoft SA
Radiology · 142d
Cleared Feb 07, 2012
MEDICAL IMAGE PROCESSING UNIT
K113360 · EAP
Humanray Co,Ltd
Radiology · 85d
Cleared Feb 03, 2012
CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL...
K113359 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 81d
Cleared Feb 03, 2012
TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS
K112953 · IYN
Teratech Corp.
Radiology · 122d
Cleared Jan 31, 2012
UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
K111305 · MQB
Meridian Medical Systems, LLC
Radiology · 267d
Cleared Jan 30, 2012
CAAS A-VALVE
K113076 · LLZ
Pie Medical Imaging BV
Radiology · 105d
Cleared Jan 30, 2012
MCKESSON HORIZON CARDIOLOGY
K112720 · LLZ
Mckesson Israel , Ltd.
Radiology · 133d
Cleared Jan 30, 2012
CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL...
K112539 · IYO
Leiker Regulatory & Quality Consulting
Radiology · 151d
Cleared Jan 30, 2012
DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE
K111385 · LLZ
Qubyx Limited
Radiology · 258d
Cleared Jan 30, 2012
CLARITY OBP SYSTEM
K111332 · IYE
Elekta , Ltd.
Radiology · 264d
Cleared Jan 27, 2012
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
K113486 · IYO
Volcano Corporation
Radiology · 65d
Cleared Jan 26, 2012
INFX-8000V WITH
K120073 · OWB
Toshibamedical Systems Corporation
Radiology · 16d
Cleared Jan 26, 2012
LOGICSCAN 64 LOGICSCAN 128
K113184 · IYN
Telemed
Radiology · 90d
Cleared Jan 26, 2012
AQUILION PRIME
K110066 · JAK
Toshiba America Medical Systems, In.C
Radiology · 381d
Cleared Jan 25, 2012
PANORAD, PANORAD SL
K113855 · KPR
Imix Adr Finland OY
Radiology · 27d
Cleared Jan 25, 2012
SONIXTABLET ULTRASOUND SCANNER
K113663 · IYN
Ultrasonix Medical Corporation
Radiology · 43d