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
9481–9504 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 21, 2001
MEDEVIEW SYSTEM
K002789 · LLZ
Medeview.Com
Radiology · 195d
Cleared Mar 21, 2001
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK
K010058 · LLZ
Witt Biomedical Corporation
Radiology · 72d
Cleared Mar 20, 2001
EXHALE DOPPLER SYSTEM
K010649 · IYN
Broncus Technologies, Inc.
Radiology · 15d
Cleared Mar 15, 2001
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
K003899 · LNH
Mri Devices Corp.
Radiology · 87d
Cleared Mar 15, 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · IZH
Planmed OY
Radiology · 58d
Cleared Mar 15, 2001
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
K010591 · ODG
Olympus Optical Co., Ltd.
Radiology · 15d
Cleared Mar 15, 2001
NEMIO
K010631 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Mar 13, 2001
3D-DOCTOR
K003746 · LLZ
Able Software Corp.
Radiology · 99d
Cleared Mar 13, 2001
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
K003947 · LNH
GE Medical Systems
Radiology · 82d
Cleared Mar 13, 2001
BEAM BLOCK TRAYS
K004015 · IYE
Arplay Medical S.A.
Radiology · 76d
Cleared Mar 13, 2001
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM
K010062 · IYE
Arplay Medical S.A.
Radiology · 64d
Cleared Mar 13, 2001
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
K010405 · IYN
Biosound Esaote, Inc.
Radiology · 29d
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