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
3841–3864 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Not Cleared Jul 19, 2017
QuantX
DEN170022 · POK
Quantitative Insights, Inc.
Radiology · 103d
Cleared Jul 18, 2017
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound...
K171824 · IYO
Edan Instruments, Inc.
Radiology · 29d
Cleared Jul 18, 2017
Arterys Viewer
K171544 · LLZ
Arterys, Inc.
Radiology · 53d
Cleared Jul 18, 2017
Faxitron Bioptics Speciemen Radiography System
K170786 · MWP
Faxitron Bioptics, LLC
Radiology · 124d
Cleared Jul 18, 2017
Examion X-AQS
K170729 · LLZ
Examion GmbH
Radiology · 131d
Cleared Jul 17, 2017
3D Endo Software
K171115 · LLZ
Dentsply Sirona
Radiology · 94d
Cleared Jul 17, 2017
!M1
K170607 · IZL
Solutions For Tomorrow AB
Radiology · 138d
Cleared Jul 14, 2017
SIGNA Premier
K171128 · LNH
Ge Medical Systems, LLC
Radiology · 88d
Cleared Jul 14, 2017
RTHawk, HeartVista Cardiac Package
K170090 · LNH
Heartvista, Inc.
Radiology · 185d
Cleared Jul 12, 2017
OEC Elite MiniView
K171800 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 26d
Cleared Jul 12, 2017
Acuson SC2000 Diagnostic Ultrasound System
K171766 · IYO
Siemens Medi Cal Solutions, Inc.
Radiology · 28d
Cleared Jul 12, 2017
TrueBeam, TrueBeam STx, Edge
K171733 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Jul 12, 2017
P50 Series Digital Color Doppler Ultrasound System
K170999 · IYN
Sonoscape Medical Corp.
Radiology · 100d
Cleared Jul 11, 2017
Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and...
K171133 · IYE
Qfix
Radiology · 85d
Cleared Jul 11, 2017
AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
K171105 · IYN
Supersonic Imagine
Radiology · 89d
Cleared Jul 11, 2017
P60 Series Digital Color Doppler Ultrasound System
K171000 · IYN
Sonoscape Medical Corp.
Radiology · 99d
Cleared Jul 10, 2017
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV...
K171034 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 95d
Cleared Jul 07, 2017
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
K171461 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 50d
Cleared Jul 07, 2017
Models 3543A, 4343A, 2929A and A843B
K170480 · MQB
Shanghai PZ Medical Technolgoy Co., Ltd.
Radiology · 141d
Cleared Jul 06, 2017
Site~Rite Halcyon Diagnostic Ultrasound System
K170870 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 105d
Cleared Jul 06, 2017
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade...
K162190 · MUH
Villa Sistemi Medicali S.P.A.
Radiology · 336d
Cleared Jul 05, 2017
Eclipse Treatment Planning System
K170969 · MUJ
Varian Medical Systems, Inc.
Radiology · 96d
Cleared Jul 05, 2017
Leica FL560
K170239 · IZI
Leica Microsystems (Schweiz) AG
Radiology · 160d
Cleared Jul 03, 2017
Enterprise Imaging XERO Viewer 8.1
K170434 · LLZ
Agfa Healthcare N.V.
Radiology · 140d