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
2761–2784 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 01, 2020
Image Guidance System for Radiotherapy
K192405 · IYE
Jiangsu Rayer Medical Technology Co.,...
Radiology · 241d
Cleared Apr 29, 2020
Evry
K200327 · LNH
Synaptive Medical, Inc.
Radiology · 79d
Cleared Apr 27, 2020
Panther Stereotactic
K193459 · MUJ
Prowess, Inc.
Radiology · 133d
Cleared Apr 24, 2020
O-arm O2 Imaging System
K200074 · OWB
Medtronic, Inc.
Radiology · 101d
Cleared Apr 23, 2020
BSD3543W
K200787 · MQB
Bontech Co., Ltd.
Radiology · 28d
Cleared Apr 22, 2020
Acuson SC2000 Diagnostic Ultrasound System
K200585 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Apr 21, 2020
NinesAI
K193351 · QAS
Nines, Inc.
Radiology · 140d
Cleared Apr 20, 2020
Sentinel
K200600 · IYE
C-Rad Positioning AB
Radiology · 42d
Cleared Apr 20, 2020
uMR 570
K200024 · LNH
Shanghai United Imaging Healthcare...
Radiology · 105d
Cleared Apr 17, 2020
LOGIQ E10
K200158 · IYN
GE Medical Systems Ultrasound &...
Radiology · 86d
Cleared Apr 16, 2020
Caption Guidance
K200755 · QJU
Caption Health
Radiology · 24d
Cleared Apr 16, 2020
ARTIS Icono
K193326 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 136d
Cleared Apr 15, 2020
AS-10
K200887 · OWB
Canon, Inc.
Radiology · 13d
Cleared Apr 15, 2020
ACUSON Sequoia Diagnostic Ultrasound System
K200707 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Apr 15, 2020
I-View Gold and Imagen Gold Dental Sensors
K200625 · MUH
Trident S.R.L
Radiology · 36d
Cleared Apr 14, 2020
JiveX
K200703 · LLZ
Visus Health IT GmbH
Radiology · 27d
Cleared Apr 14, 2020
Xelis Dental 2.0
K193369 · LLZ
Infinitt Healthcare Co., Ltd.
Radiology · 131d
Cleared Apr 13, 2020
AcuityPDR
K200726 · IZL
Radmedix, LLC
Radiology · 24d
Cleared Apr 13, 2020
CuraRad-ICH
K192167 · QAS
Curacloud Corp.
Radiology · 248d
Cleared Apr 10, 2020
DR-ID 1200SDK System
K200668 · MQB
Fujifilm Corporation
Radiology · 28d
Cleared Apr 10, 2020
ACUSON Freestyle Diagnostic Ultrasound System
K200644 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Apr 10, 2020
VARO Plan
K200078 · LLZ
3D Industrial Imaging Co., Ltd.
Radiology · 87d
Cleared Apr 10, 2020
SIGNA Premier
K193282 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 135d
Cleared Apr 10, 2020
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition...
K193215 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 141d