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
5497–5520 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 15, 2013
CPI RAD VISION
K122726 · KPR
Communications & Power Industries...
Radiology · 163d
Cleared Feb 15, 2013
TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND
K122710 · IYN
Shenzhen Delicate Electronics Co., Ltd.
Radiology · 164d
Cleared Feb 13, 2013
ULTRASOUND SCANNER FLEX FOCUS
K123254 · IYN
B-K Medical Aps
Radiology · 118d
Cleared Feb 13, 2013
DOSE TRACKING SYSTEM MODEL XIDF-DTS801
K123097 · JAA
Toshiba America Medical Systems, In.C
Radiology · 134d
Cleared Feb 12, 2013
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR...
K123938 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 54d
Cleared Feb 08, 2013
CORONIS FUSION 6MP
K130103 · LLZ
Barco N.V.
Radiology · 24d
Cleared Feb 08, 2013
4MP COLOR LCD MONITOR, RADIFORCE RX440
K130070 · LLZ
Eizo Nanao Corporation
Radiology · 28d
Cleared Feb 08, 2013
OPTIMA CT520
K123596 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 79d
Cleared Feb 08, 2013
DIAGNOSTIC ULTRASOUND SYSTEM
K123249 · IYN
Edan Instruments, Inc.
Radiology · 114d
Cleared Feb 08, 2013
SURGERY REHEARSAL PLATFORM
K123023 · LLZ
Surgical Theater, LLC
Radiology · 133d
Cleared Feb 07, 2013
M2 WRIST MRI SYSTEM
K120701 · LNH
Aspect Imaging, Ltd.
Radiology · 337d
Cleared Feb 06, 2013
SHEATHES STERILE ULTRASOUND GEL
K130041 · MUI
Sheathing Technologies, Inc.
Radiology · 29d
Cleared Feb 06, 2013
APLIO 500/400/300 V3.0
K123992 · IYN
Toshibamedical Systems Corporation
Radiology · 42d
Cleared Feb 06, 2013
CAAS INTRAVASCULAR
K123970 · LLZ
Pie Medical Imaging BV
Radiology · 42d
Cleared Feb 01, 2013
MICRODOSE SI
K123995 · MUE
Philips Digital Mammography Sweden AB
Radiology · 37d
Cleared Feb 01, 2013
E-CUBE 15
K123610 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 72d
Cleared Feb 01, 2013
INVIVO DENTAL
K123519 · LLZ
Anatomage, Inc.
Radiology · 78d
Cleared Feb 01, 2013
SYNGO, BREAST CARE
K123420 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Feb 01, 2013
VIVIX-S WIRELESS
K122865 · MQB
Vieworks Co., Ltd.
Radiology · 136d
Cleared Feb 01, 2013
PLANMED VERITY
K121418 · JAK
Planmed OY
Radiology · 266d
Cleared Jan 30, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
K122928 · MQB
Rayence Co., Ltd.
Radiology · 128d
Cleared Jan 29, 2013
IMAGEQUBE
K124048 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 29d
Cleared Jan 29, 2013
TRACTUS TISSUEMAPPER REVIEWER APPLICATION
K123901 · LLZ
Tractus Corporation
Radiology · 42d
Cleared Jan 29, 2013
GE ECHOPAC
K123894 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 42d