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
6529–6552 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 04, 2010
SYNGO.PLAZA
K093612 · LLZ
Siemens AG Medical Solutions
Radiology · 101d
Cleared Mar 03, 2010
ZEISS INFRARED 800 WITH FLOW 800 OPTION
K100468 · IZI
Carl Zeiss Surgical GmbH
Radiology · 13d
Cleared Mar 03, 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Mar 03, 2010
COLOR LCD MONITOR, MODEL RADIFORCE RS210
K092613 · LLZ
Eizo Nanao Corporation
Radiology · 189d
Cleared Mar 01, 2010
DIGITAL ULTRASOUND SCANNER
K100079 · IYO
Shenzhen Well.D Medical Electronics...
Radiology · 48d
Cleared Mar 01, 2010
ECHOPLAQUE
K092842 · LLZ
Indec Systems, Inc.
Radiology · 167d
Cleared Feb 24, 2010
FLEXIMARC, MODEL CM-0.9-2-10-GG-L
K100267 · IYE
Cortex Manufacturing, Inc.
Radiology · 26d
Cleared Feb 23, 2010
CORVUS RADIATION THERAPY PLANNING SYSTEM
K100092 · MUJ
Best Nomos
Radiology · 41d
Cleared Feb 23, 2010
SYNGO.PET&CT ONCOLOGY
K093621 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 92d
Cleared Feb 19, 2010
SONALIS
K100204 · ITX
Smith Associates
Radiology · 25d
Cleared Feb 04, 2010
CANON, MODEL URS-50RF
K093688 · OWB
Virtual Imaging, Inc.
Radiology · 66d
Cleared Feb 04, 2010
EXAPACS
K093444 · LLZ
Medincom Technology Corp
Radiology · 91d
Cleared Feb 03, 2010
R650 QDASM COLLIMATOR
K093572 · IZW
Omega Medical Imaging, Inc.
Radiology · 77d
Cleared Feb 01, 2010
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
K093563 · IYN
Philips Ultrasound, Inc.
Radiology · 75d
Cleared Feb 01, 2010
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
K093284 · MOS
Invivo Corporation
Radiology · 104d
Cleared Jan 28, 2010
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
K100067 · ITX
Toshiba America Medical Systems, In.C
Radiology · 17d
Cleared Jan 28, 2010
SHOULDER SPEEDER COIL
K093667 · MOS
Quality Electrodynamics
Radiology · 62d
Cleared Jan 27, 2010
IG 4 IMAGE GUIDED SYSTEM
K093995 · JAK
Veran Medical Technologies, Inc.
Radiology · 30d
Cleared Jan 26, 2010
RESPISENS
K092845 · IYE
Nomics
Radiology · 133d
Cleared Jan 21, 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
K093427 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d
Cleared Jan 19, 2010
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
K093849 · IYN
Medison Co., Ltd.
Radiology · 34d
Cleared Jan 19, 2010
ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
K093713 · ITX
Civco Medical Instruments
Radiology · 49d
Cleared Jan 19, 2010
3DI
K093703 · LLZ
Shina Systems , Ltd.
Radiology · 49d
Cleared Jan 19, 2010
NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/...
K093693 · MOS
Noras Mri Products GmbH
Radiology · 50d