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
7753–7776 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 08, 2005
GE DEFINIUM AMX 700, MODEL AMX 700
K052897 · IZL
General Electric Medical Systems
Radiology · 25d
Cleared Nov 08, 2005
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI...
K052987 · LNH
Noras Rontgen-Und Medizintechnik GmbH
Radiology · 15d
Cleared Nov 08, 2005
ADVANTAGE WORKSTATION 4.3.
K052995 · LLZ
Ge Healthcare
Radiology · 14d
Cleared Nov 08, 2005
ILUMA ORTHOCAT/DENTALCAT
K053046 · JAK
Imtec Corp.
Radiology · 11d
Cleared Nov 04, 2005
SYNGO NEURO DSA CT
K053024 · JAK
Siemens AG
Radiology · 14d
Cleared Nov 03, 2005
ECLIPSE TREATMENT PLANNING SYSTEM
K050296 · MUJ
Varian Medical Systems
Radiology · 269d
Cleared Nov 03, 2005
REGIUS MODEL 170 DIRECT DIGITIZER
K051998 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 101d
Cleared Nov 03, 2005
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
K052095 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 101d
Cleared Nov 03, 2005
MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM
K052541 · KPR
Avant Medical Systems
Radiology · 49d
Cleared Nov 03, 2005
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
K052704 · MOS
Invivo Corp.
Radiology · 36d
Cleared Nov 01, 2005
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
K052827 · MOS
Medrad, Inc.
Radiology · 27d
Cleared Oct 31, 2005
MIM 3.5 (CIRCA)
K052379 · LLZ
Mimvista Corp.
Radiology · 62d
Cleared Oct 31, 2005
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)
K052775 · LLZ
Siemens AG Medical Solutions
Radiology · 28d
Cleared Oct 31, 2005
ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
K052911 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Oct 28, 2005
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
K052473 · IYX
Inter Medical Medizintechnik GmbH
Radiology · 49d
Cleared Oct 28, 2005
STARSPEED SERIES CT SCANNER SYSTEMS
K052855 · JAK
Ge Healthcare
Radiology · 17d
Cleared Oct 27, 2005
MINXRAY, MODEL HF100H+
K052721 · IZL
Minxray, Inc.
Radiology · 28d
Cleared Oct 27, 2005
FOURSIGHT VIEWTOOL IMAGE VIEWER
K052895 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Oct 26, 2005
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
K052884 · OWB
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Oct 24, 2005
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
K052361 · KPQ
Nucletron Corporation
Radiology · 56d
Cleared Oct 20, 2005
LUNAR IDXA
K052581 · KGI
Ge Medical Systems Ultrasound and...
Radiology · 30d
Cleared Oct 18, 2005
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
K052433 · MWP
Bioptics, Inc.
Radiology · 42d
Cleared Oct 17, 2005
REFORMAT GATEWAY
K052284 · LLZ
Infinitt Co., Ltd.
Radiology · 56d
Cleared Oct 17, 2005
HDR IORT SHIELDED APPLICATOR
K052351 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 49d