FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
7873–7896 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Nov 22, 2005
VISTADENT AT COMPLETE, MODEL 3.1
K053010 · LLZ
Dentsply Intl., Inc.
Radiology · 27d
Cleared Nov 18, 2005
ENCOMPASS SOFTWARE PACKAGE
K053043 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 21d
Cleared Nov 17, 2005
IMAGECAST PACS
K052618 · LLZ
Idx Systems Corp.
Radiology · 55d
Cleared Nov 17, 2005
CR-PRO
K052938 · MQB
Eradlink, Inc.
Radiology · 28d
Cleared Nov 17, 2005
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009 · LNH
GE Medical Systems
Radiology · 22d
Cleared Nov 17, 2005
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
K053042 · MOS
Medrad, Inc.
Radiology · 20d
Cleared Nov 16, 2005
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
K052537 · LLZ
American Medical Sales, Inc.
Radiology · 62d