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
7897–7920 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 27, 2005
21.3INCH MONOCHROME LCD MONITOR
K052942 · LLZ
Nec-Mitsubishi Electric Visual...
Radiology · 68d
Cleared Dec 22, 2005
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K050843 · JAD
Xoft, Inc.
Radiology · 265d
Cleared Dec 22, 2005
UROVANTAGE
K053279 · OWB
Pck Electronic Industry & Trade Co.,...
Radiology · 29d
Cleared Dec 22, 2005
WEB1000
K053458 · LLZ
Agfa Corp.
Radiology · 9d
Cleared Dec 20, 2005
BRAIN VIEWRX VIEWER, VERSION 1.0
K052467 · LLZ
Kyron Clinical Imaging, Inc.
Radiology · 103d
Cleared Dec 16, 2005
LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50
K052120 · LLZ
Heeyoung Co., Ltd.
Radiology · 134d
Cleared Dec 16, 2005
MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM
K053154 · IYN
Pie Medical
Radiology · 32d
Cleared Dec 16, 2005
GE VOLUSON I
K053435 · IYN
General Electric Co.
Radiology · 7d
Cleared Dec 15, 2005
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
K052632 · LLZ
Vital Images, Inc.
Radiology · 80d
Cleared Dec 15, 2005
DDRFORMULA AND DDRFORMULA PLUS
K052943 · KPR
Swissray Medical AG
Radiology · 56d
Cleared Dec 15, 2005
DS CASSETTE
K053173 · IXA
Konica Minolta Medical & Graphic, Inc.
Radiology · 31d
Cleared Dec 09, 2005
DEXTROSCOPE & DEXTROBEAM
K053162 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 25d
Cleared Dec 09, 2005
EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
K053258 · IYN
Hitachi Medical Corp.
Radiology · 17d
Cleared Dec 09, 2005
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL...
K053346 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 7d
Cleared Dec 08, 2005
CADIMAS VERSION 1.0
K052023 · LNH
Alan Penn & Associates., Inc.
Radiology · 135d
Cleared Dec 07, 2005
EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
K053281 · LLZ
Emageon, Inc.
Radiology · 12d
Cleared Dec 07, 2005
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY)
K053325 · IYO
Mediwatch, Ltd.
Radiology · 6d
Cleared Dec 05, 2005
MEDIQ VERSION 1.0
K052963 · LLZ
Clario Medical Imaging, Inc.
Radiology · 45d
Cleared Dec 05, 2005
SYNGO DYNAMICS, VERSION 5.0
K053133 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 02, 2005
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
K052348 · IYO
Volcano Corporation
Radiology · 95d
Cleared Nov 30, 2005
IMAGE STAR II
K052610 · JAA
Lakeshore Technologies, Inc.
Radiology · 69d
Cleared Nov 23, 2005
VISION (WITH OFF-LINE REVIEW)
K052391 · IYE
Varian Medical Systems
Radiology · 84d
Cleared Nov 23, 2005
SONOLINE G60 S ULTRASOUND SYSTEM
K052894 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 40d
Cleared Nov 23, 2005
VIMPLANT
K053155 · LLZ
Cybermed, Inc.
Radiology · 9d