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
6601–6624 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 08, 2009
IMAGEGRID RADIOLOGY VIEWER SYSTEM
K092949 · LLZ
Candelis, Inc.
Radiology · 14d
Cleared Oct 07, 2009
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
K091918 · OWB
Genoray Co., Ltd.
Radiology · 99d
Cleared Oct 02, 2009
STELLAR FIDUCIAL MARKER, MODEL GFMIA
K092041 · IYE
Stellar Medical, LLC
Radiology · 87d
Cleared Oct 02, 2009
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K092058 · IYN
Sonosite,Inc.
Radiology · 86d
Cleared Oct 02, 2009
MODEL SENTINELLA 102
K092471 · IYX
General Equipment For Medical...
Radiology · 52d
Cleared Sep 28, 2009
SHEATHESISO ULTRASOUND TRANSDUCER COVER
K091828 · ITX
Sheathing Technologies, Inc.
Radiology · 101d
Cleared Sep 28, 2009
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
K092756 · ITX
Ge Vingmed Ultrasound AS
Radiology · 19d
Cleared Sep 24, 2009
XIO RTP SYSTEM
K092132 · MUJ
Computerized Medical Systems, Inc.
Radiology · 71d
Cleared Sep 24, 2009
PACSCAN PLUS, MODELS 300P AND 300AP
K092637 · ITX
Sonomed, Inc.
Radiology · 28d
Cleared Sep 22, 2009
EXTEND FRAME SYSTEM, MODEL 1009633
K092083 · IWB
Elekta Instrument AB
Radiology · 75d
Cleared Sep 22, 2009
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K092742 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 14d
Cleared Sep 18, 2009
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
K090742 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 182d
Cleared Sep 18, 2009
CFI ULTRASOUND PROBE DRAPE
K090773 · IYO
Contour Fabricators, Inc.
Radiology · 179d
Cleared Sep 18, 2009
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K091999 · IYE
Accuray, Inc.
Radiology · 78d
Cleared Sep 18, 2009
OMNIPRO INCLINE
K092018 · IYE
Iba Dosimetry GmbH
Radiology · 74d
Cleared Sep 18, 2009
ABVS WORKPLACE
K092067 · LLZ
Siemens AG Medical Solutions
Radiology · 71d
Cleared Sep 18, 2009
160MLC OPTION
K092145 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Sep 18, 2009
VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
K092653 · LHN
Medcom GmbH
Radiology · 21d
Cleared Sep 15, 2009
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
K091117 · KXK
Isoaid, LLC
Radiology · 151d
Cleared Sep 15, 2009
MODEL 1014 PC ELECTROMETER
K092019 · IYE
Sun Nuclear Corp.
Radiology · 71d
Cleared Sep 15, 2009
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
K092134 · LLZ
Statrad, LLC
Radiology · 62d
Cleared Sep 09, 2009
NSM-S15 SYSTEM
K092237 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 48d
Cleared Sep 04, 2009
INREACH SYSTEM, MODEL AAS00161-02
K092365 · JAK
Superdimension, Ltd.
Radiology · 30d
Cleared Sep 02, 2009
IMRX
K091166 · LNH
Imris, Inc.
Radiology · 133d