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
5833–5856 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 06, 2012
VIVI ERGON-X HF
K120318 · MUH
Vivi S.R.L.
Radiology · 33d
Cleared Mar 06, 2012
SONICEYE ULTRASOUND TRANSDUCER
K113832 · ITX
Blacktoe Medical Iii, Inc.
Radiology · 70d
Cleared Mar 06, 2012
HOLOGIC VISCERAL FAT SOFTWARE
K113356 · KGI
Hologic, Inc.
Radiology · 113d
Cleared Mar 02, 2012
3MP MONOCHROME LCD MONITOR, RADIFORCE GX340
K113784 · LLZ
Eizo Nanao Corporation
Radiology · 71d
Cleared Mar 02, 2012
C-THV SYSTEM
K113594 · IZI
Paieon, Inc.
Radiology · 88d
Cleared Mar 01, 2012
EUCLID (TM) TIER 1-GW ACCESS SYSTEM
K111426 · ITX
Houston Medical Robotics
Radiology · 283d
Cleared Feb 28, 2012
TOSHIBA 1.5T CARDIAC COIL
K120290 · MOS
Quality Electrodynamics
Radiology · 28d
Cleared Feb 28, 2012
MOSAIQ ONCOLOGY INFORMATION SYSTEM
K120067 · IYE
Impac Medical Systems, Inc.
Radiology · 50d
Cleared Feb 27, 2012
RADIFORCE RX240
K113844 · LLZ
Eizo Nanao Corporation
Radiology · 61d
Cleared Feb 27, 2012
CATALYST
K113276 · IYE
C-Rad Positioning AB
Radiology · 112d
Cleared Feb 27, 2012
X-RAY VVA
K112807 · LLZ
Medis Medical Imaging Systems BV
Radiology · 153d
Cleared Feb 24, 2012
Q. FREEZE (MOTION VUE2)
K113408 · KPS
Ge Medical Systems, LLC
Radiology · 98d
Cleared Feb 22, 2012
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
K112679 · LLZ
Materialise Dental NV
Radiology · 161d
Cleared Feb 17, 2012
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
K120321 · IYN
Philips Health Care
Radiology · 15d
Cleared Feb 16, 2012
VISIA NEURO
K113701 · LLZ
Mevis Medical Solutions AG
Radiology · 62d
Cleared Feb 16, 2012
3DI
K113442 · LLZ
Shina Systems , Ltd.
Radiology · 87d
Cleared Feb 16, 2012
CS IMAGING
K113419 · LLZ
Trophy
Radiology · 90d
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