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
4921–4944 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 05, 2014
AXXENT CERVICAL APPLICATOR
K141343 · JAD
Icad, Inc.
Radiology · 107d
Cleared Sep 05, 2014
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
K141248 · MUJ
Varian Medical Systems, Inc.
Radiology · 114d
Cleared Sep 05, 2014
TRUE BEAM, TRUE BEAM STX, EDGE
K140528 · IYE
Varian Medical Systems, Inc.
Radiology · 185d
Cleared Sep 05, 2014
SOPIX INSIDE, SOPIX2 INSIDE
K140013 · MUH
Sopro - Acteon Group
Radiology · 246d
Cleared Sep 05, 2014
AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT
K134025 · JAK
Toshibamedical Systems Corporation
Radiology · 249d
Cleared Sep 05, 2014
SURESUBTRACTION LUNG
K133324 · JAK
Toshiba Medical Systems Corporation,...
Radiology · 311d
Cleared Sep 04, 2014
QMASTER-H/REVO
K133797 · OAS
Telesystems Co., Ltd.
Radiology · 265d
Cleared Sep 03, 2014
SYNAPSE 3D TENSOR ANALYSIS
K141514 · LLZ
Fujifilm Meidcal Systems U.S.A.,Inc.
Radiology · 86d
Cleared Sep 03, 2014
PHOT-X IIS MODEL 505
K141293 · EHD
Takara Belmont Corporation
Radiology · 107d
Cleared Aug 29, 2014
DICOMPACS DX-R WITH FLAT PANEL
K141440 · MQB
Oehm Und Rehbein GmbH
Radiology · 88d
Cleared Aug 29, 2014
CLIMB MAMMOGRAPHY VIEWER SOFTWARE
K141364 · LLZ
Climb Medical Systems, Inc.
Radiology · 98d
Cleared Aug 29, 2014
CIVA SHEET PD-103
K140490 · KXK
Civatech Oncology, Inc.
Radiology · 183d
Cleared Aug 29, 2014
QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
K140342 · KGI
Mindways Software, Inc.
Radiology · 199d
Cleared Aug 27, 2014
OPAL CHIRO, 20/20 P-DR
K141435 · MQB
2020 Imaging
Radiology · 89d
Cleared Aug 27, 2014
CIANNA MEDICAL SGS SYSTEM
K141318 · PDW
Cianna Medical, Inc.
Radiology · 99d
Cleared Aug 27, 2014
DOSELAB PRO
K141230 · IYE
Mobius Medical Systems, LP
Radiology · 106d
Cleared Aug 26, 2014
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
K141497 · EHD
Osstem Implant Co., Ltd.
Radiology · 81d
Cleared Aug 26, 2014
VixWin Platinum
K141451 · LLZ
Imaging Sciences International (Dba...
Radiology · 85d
Cleared Aug 22, 2014
X-PORTE ULTRASOUND SYSTEM
K142017 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared Aug 22, 2014
BREAST SPEEDER CX, GRID HOLDER CX
K142002 · MOS
Quality Electrodynamics, LLC
Radiology · 30d
Cleared Aug 22, 2014
CVI42
K141480 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 79d
Cleared Aug 21, 2014
SYMBIA 6.0
K142006 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 19, 2014
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
K141979 · OWB
Philips Medical Systems Netherland BV
Radiology · 29d
Cleared Aug 19, 2014
LEICA FL800
K141136 · IZI
Leica Biosystems Richmond
Radiology · 110d