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
7369–7392 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 13, 2007
NORAS OR HEAD HOLDER
K071179 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Jun 13, 2007
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
K071378 · JAK
E-Z-Em, Inc.
Radiology · 27d
Cleared Jun 13, 2007
X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR
K071408 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 23d
Cleared Jun 11, 2007
X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
K071403 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 21d
Cleared Jun 08, 2007
LMS-LIVER
K071241 · LLZ
Median Technologies
Radiology · 36d
Cleared Jun 08, 2007
SYNGO CT ONCOLOGY SOFTWARE PACKAGE
K071310 · JAK
Siemens AG
Radiology · 30d
Cleared Jun 08, 2007
OPTICAL GUIDANCE PLATFORM
K071360 · IYE
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Jun 08, 2007
X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM
K071402 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 18d
Cleared Jun 08, 2007
X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM
K071409 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 18d
Cleared Jun 07, 2007
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
K071140 · KCY
Top Spins, Inc.
Radiology · 44d
Cleared Jun 01, 2007
RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
K071086 · LLZ
Calgary Scientific, Inc.
Radiology · 45d
Cleared May 30, 2007
DIRECT DIGITIZER, REGIUS MODEL 110
K071181 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 30d
Cleared May 30, 2007
VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
K071193 · MQB
Vidar Systems Corp.
Radiology · 30d
Cleared May 30, 2007
VITAL CONNECT 4.1
K071362 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared May 29, 2007
AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES
K062823 · JAQ
Alpha-Omega Services, Inc.
Radiology · 251d
Cleared May 25, 2007
VITREA VERSION 4.0
K071331 · LLZ
Vital Images, Inc.
Radiology · 14d
Cleared May 23, 2007
5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC
K063269 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 205d
Cleared May 22, 2007
AOS MARKER SEEDS
K062825 · KXK
Alpha-Omega Services, Inc.
Radiology · 244d
Cleared May 22, 2007
AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
K062826 · JAQ
Alpha-Omega Services, Inc.
Radiology · 244d
Cleared May 22, 2007
VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
K070831 · LLZ
Barcoview Mis Edinburgh
Radiology · 57d
Cleared May 22, 2007
FUJI IP CASSETTE TYPE PC
K070920 · IYE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 50d
Cleared May 22, 2007
RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
K071054 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 36d
Cleared May 22, 2007
.DECIMAL RANGE COMPENSATOR
K071078 · IXI
.Decimal, Inc.
Radiology · 35d
Cleared May 22, 2007
NEURO II-SE, MODELS: OR-DR-OR, OR-MB
K071099 · LNH
Imris, Inc.
Radiology · 33d