FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
6001–6024 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 12, 2011
SYNGO.CT CARDIAC FUNCTION
K110366 · JAK
Siemens AG
Radiology · 64d
Cleared Apr 08, 2011
SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K101888 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 275d
Cleared Apr 08, 2011
PORTABLE X-RAY SYSTEM
K103600 · EHD
Digimed Corporation
Radiology · 121d
Cleared Apr 08, 2011
ATAMA SYSTEM
K110411 · MOS
Monteris Medical, Inc.
Radiology · 53d
Cleared Apr 08, 2011
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
K110667 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 30d
Cleared Apr 08, 2011
A-CHANNELS LUMBAT SPINE COILS 17
K110802 · LNH
Esaote, S.P.A.
Radiology · 16d
Cleared Apr 08, 2011
UF-760AG
K110920 · ITX
Fukuda Denshi Co., Ltd.
Radiology · 7d
Cleared Apr 07, 2011
SYNAPSE 3D LIVER ANALYSIS
K110186 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 76d
Cleared Apr 07, 2011
4D SONO-SCAN 1.0
K110595 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 36d
Cleared Apr 06, 2011
NEWTOM 5G / NEWTOM 5G VERSION FP
K110260 · OAS
Qr S.R.L.
Radiology · 68d
Cleared Apr 06, 2011
TEMPOROMANIBULAR COIL 15
K110373 · MOS
Esaote, S.P.A.
Radiology · 57d
Cleared Apr 06, 2011
SYNGO MBF
K110494 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Apr 01, 2011
CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
K100714 · KPS
Cedars-Sinai Medical Center
Radiology · 385d
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 Mar 29, 2011
DUET DRF
K103038 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 166d
Cleared Mar 29, 2011
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
K103425 · OWB
Genoray America, Inc.
Radiology · 127d
Cleared Mar 29, 2011
DIGITAL RADIOGRAPHY
K103591 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 112d
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
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 25, 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102196 · OAS
VATECH Co., Ltd.
Radiology · 239d
Cleared Mar 24, 2011
BODYTOM NL 4000
K102677 · JAK
Neurologica Corporation
Radiology · 190d
Cleared Mar 24, 2011
CLEARCANVAS RIS / PACS
K110332 · LLZ
Clearcanvas, Inc.
Radiology · 49d
Cleared Mar 22, 2011
CONFIDENT SURGERY SUITE 300, MODEL CSS300
K101887 · IZD
Surgiceye GmbH
Radiology · 259d
Cleared Mar 22, 2011
ROTATING GAMMA SYSTEM INFINI (INFINI)
K102533 · IWB
Masep Medical Science &...
Radiology · 200d