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
11449–11472 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 16, 1995
IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
K952456 · JAA
Fisher Imaging Corp.
Radiology · 22d
Cleared Jun 14, 1995
MULTI-DOP X
K931801 · IYO
Dantec Medical, Inc.
Radiology · 867d
Cleared Jun 13, 1995
0.035 IN. WISE WIRE
K942927 · DQO
Boston Scientific Corp
Radiology · 356d
Cleared Jun 13, 1995
OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM
K944017 · ITX
Olympus America, Inc.
Radiology · 301d
Cleared Jun 13, 1995
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944979 · LNH
GE Medical Systems
Radiology · 245d
Cleared Jun 09, 1995
MEDICAL LINEAR ACCELERATOR
K935615 · IYE
Accelerator Systems Intl., Inc.
Radiology · 564d
Cleared Jun 07, 1995
GRAHAM-FIELD ULTRASOUND LOTION
K944596 · IMI
Chester Labs, Inc.
Radiology · 261d
Cleared Jun 05, 1995
BRAINLAB MASK SYSTEM
K945903 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 185d
Cleared Jun 05, 1995
THIN-FILM CARDIAC GATING CABLE
K946085 · LNH
General Electric Co.
Radiology · 174d
Cleared Jun 05, 1995
COMPACT 7600
K950781 · JAA
Ge Dec Medical Systems
Radiology · 104d
Cleared Jun 05, 1995
QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000
K952060 · KGI
Image Analysis, Inc.
Radiology · 34d
Cleared Jun 02, 1995
7050 ULTRASOUND IMAGING SYSTEM
K944287 · ITX
Biosound, Inc.
Radiology · 273d
Cleared May 30, 1995
INSTACINE
K942558 · LMB
Fidelity Medical, Inc.
Radiology · 364d
Cleared May 30, 1995
HIP FIXATION SYSTEM
K950866 · IYE
Medtec, Inc.
Radiology · 92d
Cleared May 30, 1995
STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER
K951141 · LMB
Star Technologies, Inc.
Radiology · 78d
Cleared May 30, 1995
ADVIEWER 2000
K952188 · IXC
Adp , Ltd.
Radiology · 21d
Cleared May 24, 1995
4000 AU ULTRASOUND IMAGING SYSTEM
K944485 · IYO
Biosound, Inc.
Radiology · 253d
Cleared May 24, 1995
AIRIS
K945155 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 215d
Cleared May 24, 1995
IM512P
K945792 · IYX
Globus Industries
Radiology · 180d
Cleared May 24, 1995
SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM
K945796 · ITX
Sharplan Lasers, Inc.
Radiology · 177d
Cleared May 24, 1995
FLUOREX DTA-400A
K946081 · JAA
Toshiba America Medical Systems, In.C
Radiology · 162d
Cleared May 24, 1995
EXPERT MORPHOMERTY SOFTWARD
K950611 · KGI
Lunar Corp.
Radiology · 103d
Cleared May 24, 1995
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
K950721 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 97d
Cleared May 24, 1995
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
K951883 · IZH
Planmed OY
Radiology · 51d