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
9025–9048 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 23, 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332 · JAK
GE Medical Systems
Radiology · 16d
Cleared Oct 22, 2002
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
K022582 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Oct 22, 2002
HCMI X-RAY
K022667 · KPR
Health Care Mfg., Inc.
Radiology · 71d
Cleared Oct 22, 2002
HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
K022737 · KPR
Health Care Mfg., Inc.
Radiology · 64d
Cleared Oct 22, 2002
CEDARA I-SOFTVIEW
K022881 · LLZ
Cedara Software Corp.
Radiology · 53d
Cleared Oct 22, 2002
USG 2000SA
K023227 · HHJ
Ultraguide , Ltd.
Radiology · 25d
Cleared Oct 22, 2002
DRYSTAR 5500
K023287 · LMC
Agfa Corp.
Radiology · 20d
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