FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
7297–7320 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 31, 2007
VISUALASE THERMAL THERAPY SYSTEM
K071328 · GEX
Biotex, Inc.
Radiology · 112d
Cleared Aug 31, 2007
OASIS RELEASE 1.0
K071584 · LLZ
Segami Corporation
Radiology · 81d
Cleared Aug 31, 2007
DAR-9400F
K072006 · IZI
Shimadzu Corp.
Radiology · 39d
Cleared Aug 30, 2007
ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM
K072285 · ITX
Aloka Co., Ltd.
Radiology · 14d
Cleared Aug 29, 2007
MHI-TM2000 LINEAR ACCELERATOR SYSTEM
K072047 · IYE
Mitsubishi Heavy Industries, Ltd.
Radiology · 35d
Cleared Aug 29, 2007
MODIFICATION TO GE LOGIQ A3
K072075 · IYN
General Electric Co.
Radiology · 30d
Cleared Aug 29, 2007
VISAGE PACS/CS, RELEASE VERSION 5.0
K072205 · LLZ
Mercury Computer Systems, Inc.
Radiology · 21d
Cleared Aug 29, 2007
ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM
K072266 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Aug 28, 2007
FIRSTVIEW
K071492 · LLZ
Riverain Medical Group,Llc
Radiology · 90d
Cleared Aug 28, 2007
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
K071806 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 57d
Cleared Aug 24, 2007
CHISON, MODEL 8300
K072210 · IYO
Chison Medical Imaging Co., Ltd.
Radiology · 15d
Cleared Aug 22, 2007
AXIOM LUMINOS DRF
K062623 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 351d
Cleared Aug 22, 2007
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K071531 · IYE
Accuray Incorporated
Radiology · 78d
Cleared Aug 17, 2007
GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
K071985 · IYN
General Electric Co.
Radiology · 29d
Cleared Aug 16, 2007
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
K071308 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 99d
Cleared Aug 16, 2007
XEBRA DICOM IMAGE BROWSER
K071894 · LLZ
Hx Technologies, Inc.
Radiology · 38d
Cleared Aug 15, 2007
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER)...
K071682 · MQB
Alara, Inc.
Radiology · 57d
Cleared Aug 15, 2007
HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
K071992 · IYE
Varian Medical Systems
Radiology · 26d
Cleared Aug 14, 2007
MAGNETOM ESSENZA
K071925 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 33d
Cleared Aug 14, 2007
20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)
K072065 · LLZ
Totoku Electric Co., Ltd.
Radiology · 18d
Cleared Aug 14, 2007
1.3M MONOCHROME LCD MONITOR MDL1908A
K072066 · LLZ
Totoku Electric Co., Ltd.
Radiology · 18d
Cleared Aug 14, 2007
IGUIDE SYSTEM
K072079 · IYE
Medical Intelligence...
Radiology · 15d
Cleared Aug 09, 2007
CODIAGNOSTIX (R) 5.72
K071636 · LLZ
Ivs Solutions AG
Radiology · 55d
Cleared Aug 09, 2007
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K071873 · MUJ
Varian Medical Systems, Inc.
Radiology · 34d