FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
9505–9528 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Feb 07, 2001
ULTRASOUND SCANNER TYPE 2101
K003041 · IYO
B & K Medical A/S
Radiology · 131d
Cleared Feb 02, 2001
P3IMRT TM
K002237 · MUJ
Adac Laboratories
Radiology · 193d
Cleared Feb 02, 2001
SELECT SEED I-125
K002429 · KXK
Nucletron Corp.
Radiology · 178d
Cleared Feb 02, 2001
SURGI-VISION GUIDEWIRE COIL
K003436 · MOS
Surgi-Vision, Inc.
Radiology · 88d
Cleared Feb 02, 2001
ODYSSEY LX, MODEL 211320
K003437 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 02, 2001
PORTALVISION
K003636 · IYE
Varian Medical Systems, Inc.
Radiology · 70d
Cleared Feb 02, 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K003655 · MOS
Mri Devices Corp.
Radiology · 67d