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
7753–7776 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 06, 2006
ART BRACHYTHERAPY APPLICATOR
K060299 · JAQ
Advanced Radiation Therapy, LLC
Radiology · 120d
Cleared Jun 06, 2006
CTS-7700
K061083 · IYO
Shantou Institute of Ultrasonic...
Radiology · 49d
Cleared Jun 06, 2006
WDS, SIZE 2 AND SIZE 2
K061114 · MUH
Cefla S.C.R.L.
Radiology · 46d
Cleared Jun 05, 2006
BRILLIANCE VOLUME
K060937 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 61d
Cleared Jun 05, 2006
IKOENGELO
K061006 · KPQ
Ikoetech, LLC
Radiology · 55d
Cleared Jun 05, 2006
TIGERVIEW PROFESSIONAL
K061035 · LLZ
Televere Systems
Radiology · 52d
Cleared Jun 01, 2006
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
K061129 · IYN
General Electric Co.
Radiology · 38d
Cleared Jun 01, 2006
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K061189 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 34d
Cleared May 30, 2006
CARDIQ FUSION
K061370 · JAK
Ge Healthcare
Radiology · 13d
Cleared May 30, 2006
CENTRICITY AW SUITE OPTION
K061372 · LLZ
Ge Healthcare Information Technologies
Radiology · 13d
Cleared May 30, 2006
QLAB QUANTIFICATION SOFTWARE
K061396 · LLZ
Philips Ultrasound, Inc.
Radiology · 11d
Cleared May 25, 2006
3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000
K061170 · MOS
Resonance Innovations, LLC
Radiology · 28d
Cleared May 25, 2006
MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR
K061303 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 15d
Cleared May 25, 2006
MEDICAL DISPLAY, MDC1900-1LG (1LR)
K061305 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 15d
Cleared May 25, 2006
VOXAR 3D ENTERPRISE WITH CARDIAMETRIX
K061326 · LLZ
Barcoview Mis Edinburgh
Radiology · 15d
Cleared May 24, 2006
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
K061132 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 30d
Cleared May 19, 2006
MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100
K060827 · IYN
Esaote, S.P.A.
Radiology · 53d
Cleared May 18, 2006
3MATIC
K060950 · LLZ
Materialise NV
Radiology · 42d
Cleared May 16, 2006
MIM 4.0 (NEURO
K060816 · LLZ
Mimvista Corp.
Radiology · 50d
Cleared May 16, 2006
SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM
K061213 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared May 15, 2006
AVANZA
K060870 · JAI
Mds Nordion
Radiology · 46d
Cleared May 15, 2006
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K061140 · IYE
Varian Medical Systems
Radiology · 21d
Cleared May 15, 2006
AQUARIUSAPS SERVER
K061214 · LLZ
Terarecon,Inc.
Radiology · 13d
Cleared May 12, 2006
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
K061187 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d