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
9529–9552 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 09, 2001
NICOLET VERSALAB
K010521 · JAF
Nicolet Biomedical
Radiology · 15d
Cleared Mar 08, 2001
NEWTOM QR-DVT 9000
K003787 · OAS
Aperio Services, LLC
Radiology · 90d
Cleared Mar 01, 2001
240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS
K003725 · IYO
Pie Medical
Radiology · 87d
Cleared Mar 01, 2001
LOGIQ 500
K010329 · IYN
General Electric Co.
Radiology · 27d
Cleared Feb 28, 2001
ALI 3D TOOL MODULE FOR MEDICAL IMAGES
K003762 · LLZ
A.L.I. Technologies, Inc.
Radiology · 84d
Cleared Feb 27, 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946 · MOS
GE Medical Systems
Radiology · 68d
Cleared Feb 22, 2001
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
K003672 · IYO
Medge Platforms, Inc.
Radiology · 86d
Cleared Feb 22, 2001
HRH-127 HEAD ARRAY COIL
K010140 · MOS
Mri Devices Corp.
Radiology · 36d
Cleared Feb 21, 2001
MEDITHERM MED2000
K003332 · LHQ
Meditherm, Inc.
Radiology · 120d
Cleared Feb 21, 2001
AURORA
K003651 · LNH
Aurora Imaging Technology, Inc.
Radiology · 86d
Cleared Feb 21, 2001
NUCAMMA BI90
K003882 · KPS
Is2 Research, Inc.
Radiology · 68d
Cleared Feb 21, 2001
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K010374 · IYN
Sonosite,Inc.
Radiology · 14d
Cleared Feb 16, 2001
REGUTHERM 952 THERMOGRAPHIC SYSTEM
K003130 · LHQ
Sie-Med, Inc.
Radiology · 133d
Cleared Feb 16, 2001
ADVANTAGE WINDOWS CT/PET FUSION
K010336 · LLZ
Ge Medical Systems, Inc.
Radiology · 11d
Cleared Feb 15, 2001
ONYX-RAD TELEMEDICINE PACS
K003607 · LLZ
Viztek, Inc.
Radiology · 85d
Cleared Feb 14, 2001
BIOLUCENT MAMMOGRAPHY CUSHION
K003795 · IZH
Biolucent, Inc.
Radiology · 68d
Cleared Feb 14, 2001
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
K003936 · IYO
Tomtec Imaging Systems GmbH
Radiology · 56d
Cleared Feb 14, 2001
KIMAX, MODEL 1024
K010187 · JAA
Medical Metrics, Inc.
Radiology · 23d
Cleared Feb 13, 2001
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
K003853 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 63d
Cleared Feb 13, 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Feb 12, 2001
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
K003510 · LLZ
Visualization Technology, Inc.
Radiology · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
K003514 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
K003515 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
MXR-2000 MOBILE X-RAY UNIT
K010304 · IZL
Irom Imaging, Inc.
Radiology · 11d