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
10897–10920 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 10, 1997
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647 · KXK
North American Scientific, Inc.
Radiology · 82d
Cleared Feb 10, 1997
SOMATOM PLUS 4 CT SCANNER
K964747 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Feb 07, 1997
ULTRASOUND GASTROSCOPE GF TYPE UM30P
K963023 · FDS
Olympus America, Inc.
Radiology · 186d
Cleared Feb 06, 1997
MLC FIT
K962335 · IYE
Impac Medical Systems, Inc.
Radiology · 234d
Cleared Feb 06, 1997
TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
K963302 · ITX
Tayman Medical, Inc.
Radiology · 168d
Cleared Feb 05, 1997
PLANNED SOPHIED CLASSIC
K962105 · IZH
Planmed OY
Radiology · 250d
Cleared Feb 04, 1997
PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
K964485 · IYE
Eliav , Ltd.
Radiology · 88d
Cleared Feb 04, 1997
MRT-35A V9.0
K964608 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Jan 30, 1997
GE STERILE DISPOSABLE EQUIPMENT COIL COVER
K964141 · MOS
Contour Fabricators, Inc.
Radiology · 107d
Cleared Jan 30, 1997
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
K965105 · IXR
U.S. Imaging Tables, Inc.
Radiology · 41d
Cleared Jan 27, 1997
LR 5200 LASER FILM RECORDER
K964414 · LMC
Bayer Corp., Agfa Div.
Radiology · 83d
Cleared Jan 27, 1997
PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT
K965072 · EHD
Kaycor Intl., Ltd.
Radiology · 39d
Cleared Jan 27, 1997
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
K965096 · IXR
U.S. Imaging Tables, Inc.
Radiology · 38d
Cleared Jan 27, 1997
KODAK MINILOADER(2000)
K970059 · IXW
Eastman Kodak Company
Radiology · 20d
Cleared Jan 24, 1997
THE ROBOLITE
K964460 · JQP
Shai Syg Motion and Innovations, Ltd.
Radiology · 78d
Cleared Jan 24, 1997
PROFILE 70000 QUADRATURE VOLUME NECK COIL
K964531 · LNH
Us Asia Instruments, Inc.
Radiology · 73d
Cleared Jan 24, 1997
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION
K964746 · JAK
GE Medical Systems
Radiology · 59d
Cleared Jan 23, 1997
PERCUPUMP II WITH EDA
K961845 · DSB
E-Z-Em, Inc.
Radiology · 255d
Cleared Jan 23, 1997
TILTING RADIOGRAPHIC TABLE (REMOTE)
K963851 · IXR
Acoma Medical Imaging, Inc.
Radiology · 120d
Cleared Jan 22, 1997
DIASONICS ITNRAOPERATIVE PROBES
K961002 · ITX
Diasonics Ultrasound
Radiology · 316d
Cleared Jan 21, 1997
NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM
K962796 · IYN
Medasonics, Inc.
Radiology · 187d
Cleared Jan 17, 1997
DIGITAL IMAGE ANALYSIS SYSTEM
K962153 · LLZ
University of Washington
Radiology · 227d
Cleared Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K964306 · LNH
General Electric Co.
Radiology · 80d
Cleared Jan 17, 1997
IPU RX-2
K964327 · LLZ
Medirex, Inc.
Radiology · 79d