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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
10177–10200 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 05, 1999
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
K984092 · IZH
Trex Medical Corp.
Radiology · 81d
Cleared Feb 02, 1999
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS
K984224 · LNH
Siemens Corp.
Radiology · 69d
Cleared Feb 02, 1999
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
K984406 · OXO
Xitec, Inc.
Radiology · 55d
Cleared Feb 02, 1999
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
K990055 · JAA
Omega Medical Imaging, Inc.
Radiology · 26d
Cleared Jan 25, 1999
BLADDERMANAGER PCI 5000 MODEL 1002
K982568 · ITX
Diagnostic Ultrasound Corp.
Radiology · 186d
Cleared Jan 25, 1999
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE...
K983905 · LMC
Eastman Kodak Company
Radiology · 83d
Cleared Jan 25, 1999
IMATION TRIMATIC DIGITAL SYSTEM
K984252 · LMA
Imation Corp.
Radiology · 59d
Cleared Jan 25, 1999
MEDRAD PHASED ARRAY NEUROVASCULAR COIL
K984257 · MOS
Medrad, Inc.
Radiology · 56d
Cleared Jan 25, 1999
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
K984274 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 56d
Cleared Jan 15, 1999
ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
K983678 · JAI
Elekta Instruments, Inc.
Radiology · 87d
Cleared Jan 14, 1999
VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
K982329 · ITX
Endosonics Corp.
Radiology · 196d
Cleared Jan 14, 1999
PACSCACHE
K983815 · LLZ
Dome Imaging Systems, Inc.
Radiology · 78d
Cleared Jan 14, 1999
AZTECH 70
K984524 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 24d
Cleared Jan 12, 1999
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
K984000 · LMD
Surgical Navigation Technologies, Inc.
Radiology · 63d
Cleared Jan 12, 1999
MEDRAD QUADRATURE CTL ARRAY COIL
K984159 · MOS
Medrad, Inc.
Radiology · 54d
Cleared Jan 12, 1999
SAGE 7
K984167 · LNI
GE Medical Systems
Radiology · 53d
Cleared Jan 12, 1999
MODIFICATION OF: RHEO DOPPLEX II
K984307 · IYN
Huntleigh Healthcare, Inc.
Radiology · 41d
Cleared Jan 07, 1999
FIELD EFFECTS MRI SYSTEM
K983902 · LNH
Intermagnetics General Corp.
Radiology · 65d
Cleared Dec 31, 1998
INSTATRAK 3000
K983529 · LLZ
Visualization Technology, Inc.
Radiology · 84d
Cleared Dec 30, 1998
RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC
K982549 · IYE
Radionics, Inc.
Radiology · 162d
Cleared Dec 30, 1998
ROCS TPS
K982791 · MUJ
Radiation Oncology Computer Systems
Radiology · 142d
Cleared Dec 30, 1998
DIGORA FOR WINDOWS 2.0
K983267 · MUH
Orion Corporation Soredex
Radiology · 104d
Cleared Dec 30, 1998
XRE COLLIMATOR WITH SPECTRAL FILTER
K984414 · IZW
Trex Medical Corp.
Radiology · 20d
Cleared Dec 23, 1998
POSITRON OPTION, MODEL NSCO-050A
K983514 · KPS
Toshiba America Medical Systems, In.C
Radiology · 77d