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
5041–5064 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 16, 2014
VSCAN WITH DUAL PROBE
K140693 · IYN
Ge Medical Sysyems Ultrasound &...
Radiology · 58d
Cleared May 15, 2014
6VT-D ULTRASOUND TRANSDUCER
K141093 · ITX
Ge Vingmed Ultrasound AS
Radiology · 17d
Cleared May 15, 2014
XGEO GR40CW
K140235 · MQB
Samsung Electronics Co., Ltd.
Radiology · 105d
Cleared May 15, 2014
RAY STATION
K140187 · MUJ
Raysearch Laboratories AB
Radiology · 111d
Cleared May 15, 2014
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
K133664 · KGI
Ge Medical Systems Ultrasound &...
Radiology · 167d
Cleared May 14, 2014
M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV...
K141010 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 26d
Cleared May 14, 2014
CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
K133620 · OAS
Imaging Sciences International
Radiology · 170d
Cleared May 13, 2014
VITREA IMAGE DENOISING SOFTWARE
K140395 · LLZ
Vital Images, Inc.
Radiology · 84d
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
K140060 · MQB
Rayence Co., Ltd.
Radiology · 123d
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR
K140056 · MQB
Rayence Co., Ltd.
Radiology · 123d
Cleared May 13, 2014
Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM
K133206 · MUH
Zuma Dental, LLC
Radiology · 208d
Cleared May 12, 2014
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
K140606 · MOS
Resonance Innovations, LLC
Radiology · 63d
Cleared May 09, 2014
ADX4000W
K134055 · MUH
Dexcowin Co., Ltd.
Radiology · 129d
Cleared May 09, 2014
LEKSELL GAMMA KNIFE PERFEXION
K133565 · IWB
Elekta Instrument AB
Radiology · 170d
Cleared May 08, 2014
HERMES MEDICAL IMAGING SUITE V5.4
K140269 · KPS
Hermes Medical Solutions AB
Radiology · 94d
Cleared May 08, 2014
16 CH MULTIPURPOSE COIL VARIETY
K140252 · MOS
Noras Rontgen-Und Medizintechnik GmbH
Radiology · 97d
Cleared May 08, 2014
SCINTILLATION GAMMA CAMERA
K140206 · KPS
Ddd-Diagnostic A/S
Radiology · 101d
Cleared May 05, 2014
HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM
K140899 · IYO
Halo Medical Technologies, LLC
Radiology · 27d
Cleared May 02, 2014
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856 · KXK
C.R. Bard, Inc.
Radiology · 29d
Cleared May 01, 2014
OEC 9800 PLUS
K132027 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 304d
Cleared Apr 30, 2014
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
K140959 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Apr 30, 2014
SOMATOM PERSPECTIVE
K133590 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 159d
Cleared Apr 28, 2014
ARTIS ONE
K133580 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 158d
Cleared Apr 28, 2014
OPTEO, VIDEOGRAPH HD
K133271 · MUH
Owandy
Radiology · 186d