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
7489–7512 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 07, 2007
PRE-LOADED VISICOIL
K070305 · IYE
Radiomed Corporation
Radiology · 34d
Cleared Mar 05, 2007
LEKSELL GAMMA KNIFE PERFEXION
K063512 · IWB
Elekta Instrument AB
Radiology · 105d
Cleared Mar 05, 2007
ULTRASOUND SCANNER PROFOCUS, MODEL 2202
K070077 · IYO
B-K Medical Aps
Radiology · 56d
Cleared Mar 02, 2007
SYNTERMED LIVE
K070089 · LLZ
Syntermed, Inc.
Radiology · 52d
Cleared Mar 01, 2007
BRACHYSCIENCES STRANDPORT
K062214 · KXK
Worldwide Medical Technologies, LLC
Radiology · 212d
Cleared Mar 01, 2007
VARIAN ESOPHAGUS BOUGIE APPLICATOR
K063815 · JAQ
Varian Medical Systems
Radiology · 69d
Cleared Mar 01, 2007
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
K063847 · FDS
Fujinon, Inc.
Radiology · 64d
Cleared Mar 01, 2007
VELOCITYAIS
K070248 · LLZ
Velocity Medical Solutions, LLC
Radiology · 35d
Cleared Feb 27, 2007
SYNGO DYNAMICS, VERSION 6.0
K070322 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Feb 15, 2007
RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS
K070131 · LLZ
Eizo Nanao Corporation
Radiology · 30d
Cleared Feb 09, 2007
TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM
K070094 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Feb 09, 2007
AEGIS
K070244 · LLZ
Sentinelle Medical, Inc.
Radiology · 15d
Cleared Feb 08, 2007
FINECUBE DENTAL CT
K063622 · OAS
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 65d
Cleared Feb 08, 2007
OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER
K063683 · IYN
Olympus Medical Systems Corporation
Radiology · 58d
Cleared Feb 08, 2007
POSITIONER
K063839 · IYE
C-Rad Positioning AB
Radiology · 44d
Cleared Feb 08, 2007
MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320
K070122 · LLZ
Eizo Nanao Corporation
Radiology · 23d
Cleared Feb 07, 2007
SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM
K070219 · MUH
Suni Medical Imaging, Inc.
Radiology · 15d
Cleared Jan 31, 2007
ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200
K063472 · IYO
Meda , Ltd.
Radiology · 77d
Cleared Jan 31, 2007
NEUTRON THERAPY SYSTEM
K063691 · IWL
Northern Illinois Univ. Outreach
Radiology · 50d
Cleared Jan 31, 2007
DEXTROSCOPE, MODEL MK10
K063730 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 44d
Cleared Jan 31, 2007
VOLUMETRIC TOMOGRAPHY
K063773 · OAS
Instrumentarium Dental, Inc.
Radiology · 41d
Cleared Jan 31, 2007
X3C DIGITAL RADIOGRAPHIC DETECTOR
K070079 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 22d
Cleared Jan 29, 2007
ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200
K063433 · IYO
Meda , Ltd.
Radiology · 77d
Cleared Jan 26, 2007
EIGEN DSA 2000
K063846 · LLZ
Eigen
Radiology · 30d