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
2713–2736 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 11, 2020
Gold Anchor
K201117 · IYE
Naslund Medical AB
Radiology · 45d
Cleared Jun 11, 2020
Versana Active
K200998 · IYN
GE Medical Systems Ultrasound and...
Radiology · 56d
Cleared Jun 11, 2020
Auto 3D Bladder Volume Tool
K200980 · IYO
Butterfly Network, Inc.
Radiology · 58d
Cleared Jun 11, 2020
MEDO ARIA
K200356 · QIH
Medo.Ai
Radiology · 119d
Cleared Jun 11, 2020
uWS-MI
K192630 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 262d
Cleared Jun 10, 2020
Intraoral Sensor
K201247 · MQB
Dentium Co., Ltd (Ict Branch)
Radiology · 30d
Cleared Jun 10, 2020
SR-8230, SR-8230S Portable X-ray Unit
K200976 · IZL
Shantou Institute of Ultrasonic...
Radiology · 58d
Cleared Jun 10, 2020
RayCare 3.1
K200487 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 104d
Cleared Jun 05, 2020
EZ-Cover
K191491 · ITX
Medxpress.Pro
Radiology · 366d
Cleared Jun 03, 2020
QLAB Advanced Quantification Software
K200974 · QIH
Philips Health Care
Radiology · 51d
Cleared Jun 03, 2020
Thales 3D Mr Scanner
K200907 · IYE
Lap GmbH Laser Applikationen
Radiology · 58d
Cleared Jun 03, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
K193021 · LNH
Canon Medical Systems Corporation
Radiology · 217d
Cleared Jun 02, 2020
MI View&GO
K201202 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jun 02, 2020
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
K201101 · MOS
Neocoil, LLC
Radiology · 39d
Cleared Jun 02, 2020
iMac 27 & PL 4.0
K200889 · PGY
Quantum-Spectra, LLC
Radiology · 60d
Cleared Jun 01, 2020
uWS-MR
K192601 · QIH
Shanghai United Imaging Healthcare...
Radiology · 255d
Cleared May 29, 2020
CFP-3131, CFP-2222
K201172 · OWB
Mx Imaging, Inc.
Radiology · 28d
Cleared May 29, 2020
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
K193602 · KXK
Lv Liberty Vision Corporation
Radiology · 158d
Cleared May 28, 2020
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic...
K200979 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 45d
Cleared May 28, 2020
Brainomix 360 e-CTA
K192692 · LLZ
Brainomix Limited
Radiology · 245d
Cleared May 26, 2020
ACUSON Juniper Diagnostic Ultrasound System
K201130 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared May 26, 2020
UNIEXPERT 2 PLUS
K200944 · KPR
Adani
Radiology · 48d
Cleared May 21, 2020
CariCloud
K200274 · LLZ
Caristo Diagnostics
Radiology · 107d
Cleared May 21, 2020
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic...
K192879 · IYN
Edan Instruments, Inc.
Radiology · 234d