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
7009–7032 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 06, 2008
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
K073650 · KPR
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 42d
Cleared Feb 06, 2008
MSK EXTREME MR SCANNER, MODEL AA5000
K080048 · LNH
Oni Medical Systems, Inc.
Radiology · 29d
Cleared Feb 01, 2008
MSTAR MPD4500
K073457 · LNH
Xinaomdt Technology Co., Ltd.
Radiology · 53d
Cleared Jan 31, 2008
VENTRI 1.1
K080124 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 14d
Cleared Jan 25, 2008
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE...
K073670 · MQB
Orex Computed Radiography, Ltd.
Radiology · 29d
Cleared Jan 24, 2008
3VISEON/SURGERY
K072653 · LLZ
3Mensio Medical Imaging BV
Radiology · 126d
Cleared Jan 23, 2008
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING,...
K073018 · IYE
Brainlab AG
Radiology · 90d
Cleared Jan 23, 2008
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
K080004 · NZT
Sicel Technologies, Inc.
Radiology · 21d
Cleared Jan 23, 2008
VASCUVIEW ULTRASOUND SYSTEM
K080049 · IYO
Escalon Medical Corp.
Radiology · 15d
Cleared Jan 23, 2008
FLAATZ 750
K080064 · MQB
Drtech Corp.
Radiology · 13d
Cleared Jan 22, 2008
NIO 5MP DISPLAY, MODEL E5620
K072875 · LLZ
Barcoview, Medical Imaging Systems
Radiology · 105d
Cleared Jan 22, 2008
VANTAGE TITAN, MODEL MRT-1504/S3
K080038 · LNH
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jan 18, 2008
MICROMRI WRIST COIL
K073131 · MOS
Micromri, Inc.
Radiology · 73d
Cleared Jan 18, 2008
MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM
K073292 · LLZ
Heeyoung Co., Ltd.
Radiology · 56d
Cleared Jan 18, 2008
OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
K073310 · MOS
Hitachi Medical Corp.
Radiology · 56d
Cleared Jan 17, 2008
IMIX INSIGHT X-RAY SYSTEMS
K073114 · KPR
Imix Adr Finland OY
Radiology · 73d
Cleared Jan 17, 2008
REGISTRATION AND FUSION
K080013 · LLZ
Agfa Healthcare Corporation
Radiology · 14d
Cleared Jan 14, 2008
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING...
K073473 · OBJ
Volcano Corporation
Radiology · 34d
Cleared Jan 10, 2008
SPY FLUORESCENT IMAGING SYSTEM
K073088 · IZI
Novadaq Technologies, Inc.
Radiology · 70d
Cleared Jan 10, 2008
SPY FLUORESCENT IMAGING SYSTEM
K073130 · IZI
Novadaq Technologies, Inc.
Radiology · 65d
Cleared Jan 10, 2008
INTUITION, MODEL 0170
K073632 · KPR
Arcoma AB
Radiology · 15d
Cleared Jan 09, 2008
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
K071287 · ITX
Shimadzu Medical Systems
Radiology · 246d
Cleared Jan 09, 2008
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
K071289 · ITX
Shimadzu Medical Systems
Radiology · 246d
Cleared Jan 09, 2008
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
K071291 · ITX
Shimadzu Medical Systems
Radiology · 246d