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
7201–7224 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jan 09, 2008
SCIMAGE PICOMENTERPRISE
K073169 · LLZ
Scimage, Inc.
Radiology · 61d
Cleared Jan 07, 2008
XORANCONNECT
K073306 · LLZ
Xoran Technologies, Inc.
Radiology · 45d
Cleared Jan 04, 2008
VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
K071554 · OBJ
Volcano Corporation
Radiology · 211d
Cleared Jan 04, 2008
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
K073167 · LNH
Ge Medical Systems, LLC
Radiology · 56d
Cleared Jan 03, 2008
SYNGO VOLUME PERFUSION-CT NEURO
K073238 · JAK
Siemens AG Medical Solutions
Radiology · 48d