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
10537–10560 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 18, 1997
EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
K972517 · KGI
Lunar Corp.
Radiology · 134d
Cleared Nov 14, 1997
SENSOR PAD
K973450 · IYO
Inventive Products, Inc.
Radiology · 64d
Cleared Nov 13, 1997
IMAGING JET SYSTEM
K970782 · JAB
General Robotic Devices, Inc.
Radiology · 254d
Cleared Nov 13, 1997
SNT LINAC ACCESSORIES
K971893 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 175d
Cleared Nov 13, 1997
REALVIEW TELEMEDICINE SYSTEM
K973065 · LLZ
Vcom Systems, Inc.
Radiology · 87d
Cleared Nov 12, 1997
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
K973131 · LMD
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Nov 10, 1997
RAVEN DRY PRINTER
K972660 · LMC
Sterling Diagnostic Imaging, Inc.
Radiology · 117d
Cleared Nov 10, 1997
REALTIME 3D DIAGNOSTIC WORKSTATION
K973010 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 10, 1997
MAMMOTEST ADAPTER DRIVER
K973400 · IZH
Fischer Imaging Corp.
Radiology · 62d
Cleared Nov 10, 1997
KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER
K973476 · EHD
Eastman Kodak Company
Radiology · 56d
Cleared Nov 10, 1997
PHILIPS INTEGRIS V5000 AND BV5000
K973482 · IZI
Philips Medical Systems North...
Radiology · 56d
Cleared Nov 10, 1997
PLANMED CYTOGUIDE
K973493 · IZH
Planmed OY
Radiology · 56d
Cleared Nov 10, 1997
SIREMOBIL CO2
K973598 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Nov 10, 1997
INFLATABLE POSITIONING CUSHIONS
K973915 · IZH
Kci New Technologies, Inc.
Radiology · 27d
Cleared Nov 05, 1997
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
K973079 · ITX
Acuson Corp.
Radiology · 79d
Cleared Nov 05, 1997
DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)
K973081 · LLZ
Howtek, Inc.
Radiology · 79d
Cleared Nov 04, 1997
CONTROL SYRINGE
K972655 · IZI
Medical Specialties Intl., Inc.
Radiology · 112d
Cleared Nov 04, 1997
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
K972903 · JAK
Imatron, Inc.
Radiology · 90d
Cleared Oct 31, 1997
APOLLO
K972882 · KGI
Norland Corp.
Radiology · 87d
Cleared Oct 28, 1997
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE-...
K972271 · KXK
Ml Strategies, Inc.
Radiology · 132d
Cleared Oct 28, 1997
XPLAN-1
K972905 · IYE
Radionics Software Applications, Inc.
Radiology · 83d
Cleared Oct 28, 1997
HELIOS LASER IMAGER 1417
K973028 · LMC
Sterling Diagnostic Imaging, Inc.
Radiology · 75d
Cleared Oct 28, 1997
MEDSTATION
K973090 · LMD
Program S.R.L.
Radiology · 71d
Cleared Oct 28, 1997
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
K973422 · LMC
Dejarnette Research Systems
Radiology · 48d