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
9001–9024 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 17, 2002
ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X...
K022824 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 52d
Cleared Oct 11, 2002
HITACHI ALTAIRE
K022390 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 80d
Cleared Oct 11, 2002
KIMAX QMA
K022585 · LLZ
Medical Metrics, Inc.
Radiology · 67d
Cleared Oct 11, 2002
VOXELPLUS PACS
K022692 · LLZ
Mevisys Co., Ltd.
Radiology · 59d
Cleared Oct 11, 2002
SMARTPACS
K022710 · LLZ
Taiwan Electronic Data Processing...
Radiology · 58d
Cleared Oct 11, 2002
E-SPEED EBT SCANNER SYSTEM
K022794 · JAK
Ge Imatron
Radiology · 49d
Cleared Oct 11, 2002
COBRASCAN CR-1 FILMLESS
K022810 · LMA
Radiographic Digital Imaging, Inc.
Radiology · 49d
Cleared Oct 11, 2002
IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
K022940 · LLZ
Intelligent Images Srl
Radiology · 37d
Cleared Oct 11, 2002
ACUITY RADIATION THERAPY SIMULATOR
K023052 · KPQ
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Oct 11, 2002
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
K023061 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 25d
Cleared Oct 11, 2002
ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
K023100 · LLZ
General Electric Medical Systems...
Radiology · 23d
Cleared Oct 11, 2002
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
K023130 · LNH
Mri Devices Corp.
Radiology · 21d
Cleared Oct 11, 2002
BBC-63-GE BREAST ARRAY COIL
K023164 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 09, 2002
EZ-SCOPE AN, EZ-SCOPE LIGHT
K022342 · IYX
Anzai Medical Co., Ltd.
Radiology · 83d
Cleared Oct 09, 2002
MODIFICATION TO FOCUS
K022630 · EHD
Instrumentarium Corp.
Radiology · 63d
Cleared Oct 09, 2002
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
K023207 · LNH
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 08, 2002
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K020027 · MUJ
Computerized Medical Systems, Inc.
Radiology · 277d
Cleared Oct 08, 2002
ARTEMIS
K021333 · IYO
Ultralink, LLC
Radiology · 165d
Cleared Oct 08, 2002
KONRAD, MODEL V.2.0
K022307 · MUJ
Mrc Systems GmbH
Radiology · 84d
Cleared Oct 08, 2002
INNOVA AND INNOVA 2000 S
K022322 · OWB
Ge Medical Systems, Inc.
Radiology · 83d
Cleared Oct 08, 2002
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K022565 · JAA
Stereotaxis, Inc.
Radiology · 67d
Cleared Oct 07, 2002
EXOMIO, MODEL 1.1
K022219 · KPQ
Medcom GmbH
Radiology · 90d
Cleared Oct 04, 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K023124 · MQB
Canon, Inc.
Radiology · 15d
Cleared Oct 03, 2002
CSV12 SOFTWARE VIEWER
K022896 · LLZ
Acuson Corp.
Radiology · 30d