Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology ×
15,695 results
2377–2400 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 07, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K211818 · LNH
Hyperfine, Inc.
Radiology · 26d
Cleared Jul 07, 2021
ONE Planner Hip
K210653 · LLZ
Orthosoft D/B/A Zimmer Cas
Radiology · 125d
Cleared Jul 01, 2021
ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
K211782 · OWB
Controlrad, Inc.
Radiology · 22d
Cleared Jul 01, 2021
decimal Bolus
K211511 · MUJ
.Decimal, LLC
Radiology · 48d
Cleared Jul 01, 2021
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K211337 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 59d
Cleared Jul 01, 2021
MAGNETOM Free.Max
K210611 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Jun 29, 2021
STAGE
K210843 · LNH
Spintech, Inc.
Radiology · 99d
Cleared Jun 29, 2021
RayStation 10.1
K210645 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 118d
Cleared Jun 29, 2021
12MP Color Digital Mammography LCD Monitor CL-S1200
K203733 · PGY
Jvckenwood Corporation
Radiology · 190d
Cleared Jun 29, 2021
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20,...
K203645 · IYN
Supersonic Imagine
Radiology · 197d
Cleared Jun 25, 2021
3D Echo v1.1
K211656 · LLZ
Jointvue, LLC
Radiology · 28d
Cleared Jun 25, 2021
Apache Ultrasound System
K211232 · IYN
Aco Healthcare Co., Ltd.
Radiology · 63d
Cleared Jun 25, 2021
BD Prevue II Peripheral Vascular Vascular Access System
K211193 · IYO
Bard Access Systems, Inc. (C.R. Bard,...
Radiology · 65d
Cleared Jun 25, 2021
Vu-Path Ultrasound System
K203657 · IYN
Crystalline Medical
Radiology · 192d
Cleared Jun 24, 2021
THD Procto Software System
K211623 · IYO
Thd Spa
Radiology · 29d
Cleared Jun 24, 2021
Virtual C DRF Digital Imaging System
K211191 · OWB
Portavision Medical, LLC
Radiology · 64d
Cleared Jun 24, 2021
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
K210959 · IYN
Samsung Medison Co., Ltd.
Radiology · 85d
Cleared Jun 22, 2021
SenoBright HD
K211215 · MUE
Ge Healthcare
Radiology · 60d
Cleared Jun 22, 2021
MICROMATE
K203720 · JAK
Isys Medizintechnik GmbH
Radiology · 183d
Cleared Jun 21, 2021
2430MCA with Xmaru W
K202902 · MUE
Rayence Co., Ltd.
Radiology · 265d
Cleared Jun 17, 2021
Precise Position
K203514 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 199d
Cleared Jun 16, 2021
Qmenta Care Platform Family
K202718 · LLZ
Mint Labs, Inc., D/B/A. Qmenta
Radiology · 272d
Cleared Jun 11, 2021
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
K210500 · IYE
Elekta Limited
Radiology · 109d
Cleared Jun 10, 2021
Fiducial Marker
K211590 · IYE
Carbon Medical Technologies, Inc.
Radiology · 17d