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
8521–8544 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 02, 2004
CT-MASS
K033774 · JAK
Medis Medical Imaging Systems BV
Radiology · 90d
Cleared Mar 01, 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372 · JAK
Ge Medical Systems, LLC
Radiology · 13d
Cleared Feb 27, 2004
ON-BOARD IMAGER DEVICE
K040192 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Feb 27, 2004
LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM
K040409 · IYN
Larsen & Toubro Limited
Radiology · 9d
Cleared Feb 26, 2004
3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316
K032555 · LLZ
Totoku Electric Co., Ltd.
Radiology · 191d
Cleared Feb 25, 2004
AUTOQUANT PLUS
K040326 · KPS
Adac Laboratories
Radiology · 15d
Cleared Feb 24, 2004
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
K033650 · OBJ
Siemens Medical Solutions USA, Inc.
Radiology · 96d
Cleared Feb 24, 2004
VITREA2 VERSION 3.5
K040305 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared Feb 20, 2004
INFRARED SCIENCES BREASTSCAN IR SYSTEM
K032350 · LHQ
Infrared Sciences Corp.
Radiology · 205d
Cleared Feb 20, 2004
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
K032443 · IZI
Shimadzu Corp.
Radiology · 196d
Cleared Feb 20, 2004
COLOR LCD DISPLAY, MODEL RADIFORCE R22
K033466 · LLZ
Eizo Nanao Corporation
Radiology · 112d
Cleared Feb 20, 2004
BRAIN PERFUSION OPTION
K033677 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 20, 2004
TROPHYPAN AND TROPHYPAN C
K033690 · EHD
Trophy Radiologie
Radiology · 88d
Cleared Feb 20, 2004
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
K033821 · LMC
Eastman Kodak Company
Radiology · 73d
Cleared Feb 20, 2004
PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
K034054 · JAI
Med-Tec,Inc.
Radiology · 52d
Cleared Feb 20, 2004
GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587
K040251 · IYN
Ge Med. Systems Ultrasound & Prim....
Radiology · 17d
Cleared Feb 19, 2004
INTEGRIS 3D-RA, RELEASE 4.2
K040254 · LLZ
Philips Medical Systems North America...
Radiology · 15d
Cleared Feb 17, 2004
QLAB QUANTIFICATION SOFTWARE
K040227 · LLZ
Philips Ultrasound
Radiology · 15d
Cleared Feb 12, 2004
SIREMOBILE C06
K040066 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Feb 10, 2004
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K032067 · JAQ
Proxima Therapeutics, Inc.
Radiology · 222d
Cleared Feb 09, 2004
CSTAT, MODELS 09-0014-01 AND 09-0014-02
K032125 · DXC
Vascular Control Systems, Inc.
Radiology · 214d
Cleared Feb 06, 2004
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
K040142 · LLZ
Adac Laboratories
Radiology · 15d
Cleared Feb 04, 2004
SIMULIX EVOLUTION
K033470 · KPQ
Nucletron Corporation
Radiology · 93d
Cleared Feb 02, 2004
CHASE CARDIAC ANALYSIS SYSTEM
K032531 · LLZ
Chase Medical, Inc.
Radiology · 171d