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
7513–7536 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 14, 2006
2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC
K063579 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 14d
Cleared Dec 14, 2006
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
K063580 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Dec 12, 2006
MEDWEB ADVANCED 3D WEB PACS
K063221 · LLZ
Nexsys Electronics, Inc.
Radiology · 49d
Cleared Dec 12, 2006
RCHIVE PACS
K063253 · LLZ
Sobha Renaissance Information...
Radiology · 46d
Cleared Dec 12, 2006
ACCULOC BREAST LOCALIZATION SYSTEM
K063274 · IYE
Northwest Medical Physics Equipment,...
Radiology · 43d
Cleared Dec 12, 2006
OPAL-RAD
K063337 · LLZ
Viztek, Inc.
Radiology · 36d
Cleared Dec 12, 2006
IMCO-STAT
K063392 · LLZ
Imco Technologies
Radiology · 33d
Cleared Dec 12, 2006
VISUALASE ENVISION SOFTWARE SYSTEM
K063505 · LLZ
Biotex, Inc.
Radiology · 22d
Cleared Dec 12, 2006
ECHELON MR-RCC-150 CARDIAC COIL
K063513 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 21d
Cleared Dec 07, 2006
NOVAPACS
K063153 · LLZ
Novarad Corp.
Radiology · 52d
Cleared Dec 07, 2006
20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)
K063200 · LLZ
Totoku Electric Co., Ltd.
Radiology · 48d
Cleared Dec 06, 2006
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
K063500 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Dec 04, 2006
21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2)
K063199 · LLZ
Totoku Electric Co., Ltd.
Radiology · 45d
Cleared Nov 30, 2006
RAPID STRAND RX
K063177 · KXK
Oncura, Inc.
Radiology · 42d
Cleared Nov 30, 2006
DEL-IMS
K063188 · LLZ
Del Medical Imaging Corp.
Radiology · 41d
Cleared Nov 30, 2006
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)
K063197 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Nov 30, 2006
21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)
K063198 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Nov 30, 2006
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS,...
K063312 · DQO
Boston Scientific Corp
Radiology · 28d
Cleared Nov 30, 2006
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
K063342 · MOS
Medrad, Inc.
Radiology · 24d
Cleared Nov 30, 2006
SYNGO NEURO PBV CT
K063507 · JAK
Siemens AG
Radiology · 10d
Cleared Nov 28, 2006
CAAS QCA 3D
K063344 · LLZ
Pie Medical Imaging BV
Radiology · 22d
Cleared Nov 22, 2006
MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K061608 · IYN
Hitachi Medical Corp.
Radiology · 166d
Cleared Nov 22, 2006
PTW DAVID IMRT QC VERIFICATION SYSTEM
K062817 · IYE
Ptw-New York Corp.
Radiology · 63d
Cleared Nov 22, 2006
IVUS ENHANCER
K062985 · LLZ
Indec Systems, Inc.
Radiology · 54d