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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
10609–10632 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 21, 1997
PROSTATE SEEDING NEEDLE
K973184 · IWJ
Promex, Inc.
Radiology · 88d
Cleared Nov 21, 1997
ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100
K973642 · EHD
Instrumentarium Imaging, Inc.
Radiology · 58d
Cleared Nov 21, 1997
GIOTTO HT
K973856 · IZH
Sitco, Inc.
Radiology · 43d
Cleared Nov 21, 1997
VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE
K973889 · IYE
Varian Medical Systems, Inc.
Radiology · 38d
Cleared Nov 20, 1997
MACOM
K973148 · LLZ
A.Stein - Regulatory Affairs Consulting
Radiology · 90d
Cleared Nov 19, 1997
MEDIMAGE
K972215 · LLZ
Vepro - Computersysteme GmbH
Radiology · 159d
Cleared Nov 19, 1997
IMATION SE-204 LASER IMAGER
K972822 · LMC
Imation Enterprises Corp.
Radiology · 112d
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