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
6169–6192 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 01, 2011
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
K110610 · MOS
Ge Medical Systems, LLC
Radiology · 29d
Cleared Apr 01, 2011
CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
K100714 · KPS
Cedars-Sinai Medical Center
Radiology · 385d
Cleared Mar 29, 2011
MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
K110591 · MOS
Mr Instruments, Inc.
Radiology · 27d
Cleared Mar 29, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
K103596 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 111d
Cleared Mar 29, 2011
DIGITAL RADIOGRAPHY
K103591 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 112d
Cleared Mar 29, 2011
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
K103425 · OWB
Genoray America, Inc.
Radiology · 127d
Cleared Mar 29, 2011
DUET DRF
K103038 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 166d
Cleared Mar 25, 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102196 · OAS
VATECH Co., Ltd.
Radiology · 239d
Cleared Mar 24, 2011
CLEARCANVAS RIS / PACS
K110332 · LLZ
Clearcanvas, Inc.
Radiology · 49d
Cleared Mar 24, 2011
BODYTOM NL 4000
K102677 · JAK
Neurologica Corporation
Radiology · 190d
Cleared Mar 22, 2011
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
K110151 · LNH
Philips Health Care
Radiology · 63d
Cleared Mar 22, 2011
ORTHOPHOS XG 3D / CEPH
K103711 · OAS
Sirona Dental Systems GmbH
Radiology · 92d
Cleared Mar 22, 2011
IDEAL IQ SOFTWARE OPTION
K103411 · LNH
GE Medical Systems
Radiology · 120d
Cleared Mar 22, 2011
ROTATING GAMMA SYSTEM INFINI (INFINI)
K102533 · IWB
Masep Medical Science &...
Radiology · 200d
Cleared Mar 22, 2011
CONFIDENT SURGERY SUITE 300, MODEL CSS300
K101887 · IZD
Surgiceye GmbH
Radiology · 259d
Cleared Mar 18, 2011
SENTINELLA 102
K110601 · IYX
General Equipment For Medical...
Radiology · 16d
Cleared Mar 18, 2011
PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS
K110482 · IYN
Teratech Corp.
Radiology · 28d
Cleared Mar 18, 2011
INTRA SKAN DC
K103579 · EHD
Skanray Technologies
Radiology · 102d
Cleared Mar 17, 2011
ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY
K110371 · MUH
Panoramic Corp.
Radiology · 37d
Cleared Mar 17, 2011
PLANMECA PROMAX 3D MID
K103689 · MUH
Planmeca Oy
Radiology · 90d
Cleared Mar 17, 2011
AYCAN WORKSTATION OSIRIX PRO
K103546 · LLZ
Aycan Digitalsysteme GmbH
Radiology · 105d
Cleared Mar 17, 2011
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
K103416 · OWB
Infimed, Inc.
Radiology · 115d
Cleared Mar 16, 2011
DOPPLER MONITOR
K110347 · DPW
Cook Vascular, Inc.
Radiology · 37d
Cleared Mar 16, 2011
MODALIXX
K110108 · LLZ
Ampronix, Inc.
Radiology · 61d