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
3673–3696 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 19, 2017
Veraview X800
K171012 · OAS
J. Morita USA, Inc.
Radiology · 259d
Cleared Dec 18, 2017
DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
K172918 · MUH
Kavo Dental Technologies, LLC
Radiology · 84d
Cleared Dec 14, 2017
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
K173434 · PGY
Jvckenwood Corporation
Radiology · 42d
Cleared Dec 14, 2017
Infinix-i, INFX-8000V, V7.0
K172863 · OWB
Toshibamedical Systems Corporation
Radiology · 85d
Cleared Dec 14, 2017
E-CUBE 8
K172732 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 94d
Cleared Dec 13, 2017
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
K173369 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 47d
Cleared Dec 13, 2017
InnoSight Diagnostic Ultrasound System
K172056 · IYO
Qisda Corporation
Radiology · 160d
Cleared Dec 12, 2017
Advanced Diffusion Analysis (ADA) application
K173467 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 34d
Cleared Dec 12, 2017
Xario 200 Diagnostic Ultrasound System V6.0
K172276 · IYN
Toshibamedical Systems Corporation
Radiology · 137d
Cleared Dec 11, 2017
Optima XR646 HD
K173612 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 19d
Cleared Dec 08, 2017
Merge PACS
K173475 · LLZ
Merge Healthcare Incorporated
Radiology · 29d
Cleared Dec 08, 2017
8ch Flex Suite
K172222 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 137d
Cleared Dec 08, 2017
Med-Hot Thermal Imaging Systems
K171928 · LHQ
Med-Hot Thermal Imaging, Inc.
Radiology · 164d
Cleared Dec 08, 2017
Clear Guide SCENERGY
K171677 · JAK
Clear Guide Medical
Radiology · 185d
Cleared Dec 07, 2017
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300...
K173000 · IYN
Shantou Institute of Ultrasonic...
Radiology · 71d
Cleared Dec 07, 2017
NeuViz 16 Essence Multi-slice CT Scanner System
K171198 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 227d
Cleared Dec 07, 2017
Lilium a-200E
K170046 · IYO
Lilium Otsuka Co., Ltd.
Radiology · 336d
Cleared Dec 05, 2017
P20 Series Digital Color Doppler Ultrasound System
K172993 · IYN
Sonoscape Medical Corp.
Radiology · 69d
Cleared Dec 01, 2017
P10 Series Digital Color Doppler Ultrasound System
K173058 · IYN
Sonoscape Medical Corp.
Radiology · 64d
Cleared Dec 01, 2017
DUS-6000 Digital Ultrasonic Diagnostic Imaging System
K172931 · IYO
Advanced Instrumentations, Inc.
Radiology · 67d
Cleared Dec 01, 2017
EZFluence
K171352 · IYE
Radformation, Inc.
Radiology · 206d
Cleared Nov 29, 2017
Collision Check
K171350 · IYE
Radformation, Inc.
Radiology · 204d
Cleared Nov 28, 2017
3.0T 16ch Breast Coil
K173377 · MOS
Neocoil, LLC
Radiology · 29d
Cleared Nov 28, 2017
DuoFLEX Coil Suite
K173290 · MOS
Mr Instruments, Inc.
Radiology · 43d