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
4129–4152 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 03, 2016
Senographe Pristina
K162268 · MUE
Ge Healthcare
Radiology · 83d
Cleared Nov 03, 2016
MicrUs
K161968 · IYO
Telemed
Radiology · 108d
Cleared Nov 03, 2016
Vitrea CT Dual Energy Image View
K161157 · JAK
Vital Images, Inc.
Radiology · 192d
Cleared Nov 03, 2016
FONA Pan/Ceph
K161131 · MUH
Fona S.R.L
Radiology · 196d
Cleared Nov 01, 2016
Xario 200 Diagnostic Ultrasound System V5.0
K162155 · IYN
Toshibamedical Systems Corporation
Radiology · 91d
Cleared Nov 01, 2016
Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing...
K162002 · IYE
Zdi, Solutions, LLC
Radiology · 104d
Cleared Oct 28, 2016
Arterys Software v2.0
K162513 · LLZ
Arterys, Inc.
Radiology · 50d
Cleared Oct 28, 2016
PaX-i3D Green Premium (Model: PCT-90LH)
K160882 · OAS
VATECH Co., Ltd.
Radiology · 211d
Cleared Oct 28, 2016
ClearVision ExamVue Flat Panel Detector
K160143 · MQB
Jpi Healthcare, Inc.
Radiology · 281d
Cleared Oct 25, 2016
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT
K162736 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Oct 25, 2016
syngo.via RT Image Suite
K162370 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 62d
Cleared Oct 25, 2016
vRad PACS with Mammography
K162145 · LLZ
Virtual Radiologic Corporation
Radiology · 85d
Cleared Oct 25, 2016
G-scan Brio, S-scan
K161973 · LNH
Esaote, S.P.A.
Radiology · 99d
Cleared Oct 21, 2016
Paragon 2
K162687 · IZL
Meridian Medical Systems, LLC
Radiology · 24d
Cleared Oct 21, 2016
Artemis
K162474 · LLZ
Eigen
Radiology · 45d
Cleared Oct 21, 2016
Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz...
K160442 · IYN
Neural Analytics, Inc.
Radiology · 247d
Cleared Oct 20, 2016
Green Smart (Model: PHT-35LHS)
K162660 · OAS
VATECH Co., Ltd.
Radiology · 24d
Cleared Oct 20, 2016
IQM Integral Quality Monitor (also IQM)
K162629 · IYE
Irt Systems
Radiology · 29d
Cleared Oct 20, 2016
QuantumCam
K161674 · KPS
Ddd-Diagnostic A/S
Radiology · 126d
Cleared Oct 20, 2016
Advanced Breast Template System
K161540 · JAQ
Varian Medical Systems, Inc.
Radiology · 139d
Cleared Oct 19, 2016
Ultrasound System SONIMAGE HS1
K162065 · IYN
Konica Minolta, Inc.
Radiology · 85d
Cleared Oct 18, 2016
16ch T/R Knee Coil
K162029 · MOS
Quality Electrodynamics, LLC
Radiology · 88d
Cleared Oct 18, 2016
IntelliSpace Portal Platform
K162025 · LLZ
Philips Medical Systems Nederlands B.V.
Radiology · 88d
Cleared Oct 18, 2016
NOBLUS™ Ultrasound Diagnostic System
K160559 · IYN
Hitachi Medical Corporation
Radiology · 232d