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
2305–2328 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jun 10, 2021
syngo.via MI WorkFlows, Scenium, syngo MBF
K211459 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jun 10, 2021
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9...
K210699 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 93d
Cleared Jun 10, 2021
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9...
K210416 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d