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
5425–5448 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 30, 2013
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI...
K123941 · JAQ
Spencer Fillmore
Radiology · 131d
Cleared Apr 30, 2013
CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM
K122888 · IYE
Cdr Systems, Inc.
Radiology · 222d
Cleared Apr 29, 2013
DIAGNOSTICPRO EDGE
K130406 · LMA
Vidar Systems Corp.
Radiology · 69d
Cleared Apr 26, 2013
ICRCO 3600M
K122510 · MUE
Icrco, Inc.
Radiology · 252d
Cleared Apr 22, 2013
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
K130318 · JAA
Varian Medical Systems, X-Ray...
Radiology · 73d
Cleared Apr 19, 2013
ECAT SCINTRON PET
K130269 · KPS
Miegmbh
Radiology · 74d
Cleared Apr 18, 2013
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
K130883 · MQB
Sedecal., Sa.
Radiology · 20d
Cleared Apr 18, 2013
MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR
K130772 · LLZ
Nec Display Solutions , Ltd.
Radiology · 29d
Cleared Apr 18, 2013
MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
K130770 · LLZ
Nec Display Solutions , Ltd.
Radiology · 29d
Cleared Apr 18, 2013
PREXION3D ECLIPSE
K122199 · OAS
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 268d
Cleared Apr 12, 2013
ZMED VP4000
K130929 · LLZ
Zmed, Inc.
Radiology · 9d
Cleared Apr 12, 2013
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
K130884 · LLZ
Ge Medical Systems F.I. Haifa
Radiology · 14d
Cleared Apr 12, 2013
UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM
K130803 · IYN
Samsung Medison Co., Ltd.
Radiology · 21d
Cleared Apr 12, 2013
BIOMARC GOLD FIDUCIAL MARKER
K130678 · IYE
Carbon Medical Technologies, Inc.
Radiology · 30d
Cleared Apr 12, 2013
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K130119 · IYN
Sonoscape Company Limited
Radiology · 86d
Cleared Apr 12, 2013
PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA...
K122537 · IYN
Hitachi Aloka Medical,Ltd. (Hitachi...
Radiology · 235d
Cleared Apr 10, 2013
SPINE COIL
K123708 · MOS
Usa Paramed Medical Systems, Inc.
Radiology · 128d
Cleared Apr 09, 2013
SYNAPSE 3D CARDIAC TOOLS
K130383 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 54d
Cleared Apr 05, 2013
NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM
K130308 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 57d
Cleared Apr 05, 2013
INNOVA EPVISION 2.0, INNOVA EPVISION 2.0
K130069 · LLZ
Ge Healthcare
Radiology · 84d
Cleared Apr 05, 2013
FIBROSCAN
K123806 · IYO
Echosens
Radiology · 116d
Cleared Apr 04, 2013
AGILITY
K123808 · IYE
Elekta , Ltd.
Radiology · 114d
Cleared Apr 04, 2013
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS
K123263 · MUJ
Eckert & Ziegler Bebig GmbH
Radiology · 168d
Cleared Apr 03, 2013
SPEQRT ULTRASOUND SYSTEM
K130659 · IYN
Signostics Pty, Ltd.
Radiology · 22d