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
8449–8472 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 20, 2003
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502 · JAK
Ge Medical Systems, LLC
Radiology · 15d
Cleared Nov 19, 2003
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
K033345 · KPR
Analogic Corp.
Radiology · 30d
Cleared Nov 19, 2003
GE PRECISION MPI
K033486 · OWB
Nrt-Nordisk Rontgen Teknik A/S
Radiology · 15d
Cleared Nov 14, 2003
MOBILETTE XP AND MOBILETT XPHYBRID
K033238 · IZL
Siemens Medical Systems, Inc.
Radiology · 39d
Cleared Nov 14, 2003
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K033353 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Nov 12, 2003
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
K033066 · OXO
Xitec Holdings, LLC
Radiology · 44d
Cleared Nov 12, 2003
COMPACT DIGITAL CARDIAC CAMERA (CDCC)
K033199 · KPS
Is2 Medical Systems, Inc.
Radiology · 41d
Cleared Nov 12, 2003
MODIFICATION TO: HI-ART SYSTEM
K033347 · IYE
Tomotherapy Incorporated
Radiology · 23d
Cleared Nov 10, 2003
ANZAI AZ-733 RESPIRATORY GATING SYSTEM
K031385 · LHN
Anzai Medical Co., Ltd.
Radiology · 193d
Cleared Nov 10, 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 10, 2003
MEDICHEART, MODEL RELEASE 1
K032823 · JAK
Medicsight
Radiology · 61d
Cleared Nov 10, 2003
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
K033418 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 07, 2003
DGH 55 HANDHELD PACHYMETER (PACHMATE)
K033385 · IYO
Dgh Technology, Inc.
Radiology · 15d
Cleared Nov 06, 2003
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K033374 · OEB
Siemens AG Medical Solutions
Radiology · 15d
Cleared Nov 05, 2003
ECHOCONNEX COMMUNICATOR
K033093 · LLZ
Connexmd
Radiology · 37d
Cleared Nov 05, 2003
MEDIC COLON MODEL, RELEASE 1
K033102 · JAK
Medicsight
Radiology · 37d
Cleared Nov 05, 2003
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224 · KGI
Hologic, Inc.
Radiology · 30d
Cleared Nov 05, 2003
VIATRONIX V3D VASCULAR, REVISION 1.0
K033361 · LLZ
Viatronix, Inc.
Radiology · 15d
Cleared Nov 05, 2003
TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS...
K033367 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Oct 31, 2003
FUKUDA DENSHI MODEL FF SONIC UF-750XT
K033209 · IYN
Fukuda Denshi USA, Inc.
Radiology · 28d
Cleared Oct 30, 2003
RATIONAL IMAGING PACS
K031473 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 174d
Cleared Oct 30, 2003
GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
K032656 · IYN
Ge Med. Systems Ultrasound & Prim....
Radiology · 63d
Cleared Oct 30, 2003
ADVANTAGE 4D OPTION
K032915 · JAK
Ge Medical Systems, LLC
Radiology · 38d