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
3529–3552 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 13, 2018
SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO
K173632 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Apr 13, 2018
uMI 780 PET/CT System
K172143 · KPS
Shanghai United Imaging Healthcare...
Radiology · 270d
Cleared Apr 13, 2018
LIGHTSonic BUBM
K170761 · IYO
Lightmed USA, Inc.
Radiology · 396d
Cleared Apr 13, 2018
Best Instruminal Applicator
K162499 · JAQ
Best Medical International, Inc.
Radiology · 583d
Cleared Apr 12, 2018
48CH Head Coil
K180666 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 29d
Cleared Apr 12, 2018
Uroview FD II
K180651 · JAA
Pausch Medical GmbH
Radiology · 30d
Cleared Apr 12, 2018
ZED Link
K180549 · LLZ
Zed Technologies
Radiology · 42d
Cleared Apr 11, 2018
PET Digital Gating
K180318 · KPS
Ge Medical Systems, LLC
Radiology · 65d
Cleared Apr 11, 2018
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular...
K173860 · IYO
Volcano Corporation
Radiology · 112d
Cleared Apr 06, 2018
Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung
K170570 · IYE
Varian Medical Systems, Inc.
Radiology · 403d
Cleared Apr 05, 2018
DR 800 with MUSICA Dynamic
K180589 · JAA
Agfa Healthcare N.V.
Radiology · 30d
Cleared Apr 05, 2018
PowerLook Density Assessment Software
K180125 · LLZ
Icad, Inc.
Radiology · 79d
Cleared Apr 05, 2018
syngo.via MI Workflows
K173897 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 104d
Cleared Apr 05, 2018
uWS-MI
K172998 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Apr 05, 2018
Corin Optimized Positioning System (OPS™) Plan
K171847 · LLZ
Corin U.S.A. Limited
Radiology · 288d
Cleared Apr 04, 2018
SciMoCa
K180595 · IYE
Radialogica, LLC
Radiology · 29d
Cleared Apr 04, 2018
GammaPod
K180571 · IWB
Xcision Medical Systems, LLC
Radiology · 30d
Cleared Apr 04, 2018
MobileX Portable X-ray System
K180561 · EHD
Denterprise International, Inc.
Radiology · 30d
Cleared Apr 04, 2018
Scenium VE20 Software
K173597 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Apr 04, 2018
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
K173079 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 187d
Cleared Apr 04, 2018
SIMPLANT 18
K172239 · LLZ
Dentsply Sirona
Radiology · 252d
Cleared Apr 02, 2018
Varian Head Frame
K180586 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Apr 02, 2018
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
K173639 · OWB
Siemens Medi Cal Solutions, Inc.
Radiology · 129d
Cleared Mar 30, 2018
G-scan Brio
K180592 · LNH
Esaote, S.P.A.
Radiology · 24d