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
4393–4416 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 26, 2016
LOGIQ S7 Expert
K160182 · IYN
Ge Healthcare
Radiology · 30d
Cleared Feb 26, 2016
E-CUBE i7
K153424 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 93d
Cleared Feb 26, 2016
VIVIX-S 1717N
K152894 · MQB
Vieworks Co., Ltd.
Radiology · 149d
Cleared Feb 26, 2016
VIVIX-S 1012N
K152855 · MQB
Vieworks Co., Ltd.
Radiology · 150d
Cleared Feb 25, 2016
DIVA ZSP2105CMI with QUBYX PerfectLum bundle
K160328 · PGY
The Linden Group Corp
Radiology · 20d
Cleared Feb 25, 2016
Voluson S6, Voluson S8, Voluson S10
K160184 · IYN
Ge Healthcare
Radiology · 29d
Cleared Feb 25, 2016
McLaren Proton Therapy System
K160063 · LHN
Mclaren Health Care Corporation
Radiology · 43d
Cleared Feb 25, 2016
Axxent Electronic Brachytherapy System Model 110 XP 1200
K153570 · JAD
Icad, Inc.
Radiology · 73d
Cleared Feb 25, 2016
IMPLANT 3D
K153091 · LLZ
Media Lab S.R.L.
Radiology · 122d
Cleared Feb 25, 2016
MedicVOD System
K151737 · LLZ
Orpheus Medical , Ltd.
Radiology · 244d
Cleared Feb 25, 2016
MRCAT
K151435 · MUJ
Philips Medical Systems MR Finland
Radiology · 273d
Cleared Feb 23, 2016
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
K160326 · PGY
Jvckenwood Corporation
Radiology · 18d
Cleared Feb 23, 2016
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
K160247 · PGY
Eizo Corporation
Radiology · 22d
Cleared Feb 23, 2016
FS-PACS
K152034 · LLZ
Ec-Web Co., Ltd.
Radiology · 216d
Cleared Feb 19, 2016
I4 (Integrated Intelligent Imaging Informatics) system
K160315 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 14d
Cleared Feb 19, 2016
syngo.CT Single Source Dual Energy (Twin Beam)
K153220 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 105d
Cleared Feb 18, 2016
DBSWIN and VistaEasy Imaging Software
K143290 · LLZ
Durr Dental AG
Radiology · 458d
Cleared Feb 17, 2016
CliniscanSM MRI
K153593 · LLZ
Picofemto, LLC
Radiology · 63d
Cleared Feb 16, 2016
Radiance V3
K153368 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 85d
Cleared Feb 12, 2016
TraumaCad Mobile Release 2.0
K160001 · LLZ
Voyant Health, Ltd.
Radiology · 39d
Cleared Feb 12, 2016
CARESTREAM Vue PACS
K153103 · LLZ
Carestream Health, Inc.
Radiology · 109d
Cleared Feb 12, 2016
Clear Guide SCENERGY
K153004 · JAK
Clear Guide Medical
Radiology · 122d
Cleared Feb 10, 2016
Cios Select
K153232 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Feb 10, 2016
TIO-H DIGITAL RADIOGRAPHY SENSOR
K153144 · MUH
Denttio, Inc.
Radiology · 103d