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
6193–6216 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 08, 2011
PORTABLE X-RAY SYSTEM
K103600 · EHD
Digimed Corporation
Radiology · 121d
Cleared Apr 08, 2011
SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K101888 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 275d
Cleared Apr 07, 2011
4D SONO-SCAN 1.0
K110595 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 36d
Cleared Apr 07, 2011
SYNAPSE 3D LIVER ANALYSIS
K110186 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 76d
Cleared Apr 06, 2011
SYNGO MBF
K110494 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Apr 06, 2011
TEMPOROMANIBULAR COIL 15
K110373 · MOS
Esaote, S.P.A.
Radiology · 57d
Cleared Apr 06, 2011
NEWTOM 5G / NEWTOM 5G VERSION FP
K110260 · OAS
Qr S.R.L.
Radiology · 68d
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