FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
9337–9360 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 12, 2001
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
K003837 · OXO
Ge Oec Medical Systems
Radiology · 90d
Cleared Mar 12, 2001
ATLAS MULTI-PURPOSE DSA SYSTEM
K010391 · IZI
Cares Built, Inc.
Radiology · 31d
Cleared Mar 12, 2001
ATHENA REMOTE CONTROLLED RF SYSTEM
K010392 · JAA
Cares Built, Inc.
Radiology · 32d
Cleared Mar 12, 2001
APOLLO MOBILE C ARM SYSTEM
K010393 · OXO
Cares Built, Inc.
Radiology · 32d
Cleared Mar 12, 2001
PHILIPS BV PULSERA/ENDURA
K010435 · OWB
Philips Medical Systems, Inc.
Radiology · 27d
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