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
11185–11208 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 05, 1995
PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM
K954165 · IYE
Ptw-New York Corp.
Radiology · 91d
Cleared Dec 05, 1995
CRISPICS
K954211 · LLZ
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared Nov 30, 1995
OSTEO-RAY 100
K953404 · IZL
Micro-Focus Imaging., Inc.
Radiology · 133d
Cleared Nov 24, 1995
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
K942604 · LNH
GE Medical Systems
Radiology · 541d
Cleared Nov 24, 1995
LASERNET IMAGE MANAGER/PRINT SERVER
K952485 · LMA
Frantz Imaging, Inc.
Radiology · 178d
Cleared Nov 24, 1995
VERTEX EPIC MCD
K952684 · KPS
Adac Laboratories
Radiology · 165d
Cleared Nov 24, 1995
VOXELVIEW
K953259 · LLZ
Vital Images, Inc.
Radiology · 135d
Cleared Nov 24, 1995
PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
K953876 · ODG
Pentax Precision Instrument Corp.
Radiology · 109d
Cleared Nov 24, 1995
GYREX PRIVILEGE
K954039 · LNH
Elscint, Inc.
Radiology · 88d
Cleared Nov 24, 1995
MPH50, MPH65, AND MPH80
K954666 · IZO
GE Medical Systems
Radiology · 45d
Cleared Nov 22, 1995
WALLACH DIGITAL IMAGING SYSTEM
K950630 · LMB
Wallach Surgical Devices, Inc.
Radiology · 282d
Cleared Nov 22, 1995
INSPECT/PROSPECT
K952564 · KPS
Adac Laboratories
Radiology · 173d
Cleared Nov 22, 1995
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER
K952913 · JAQ
Varian Assoc., Inc.
Radiology · 149d
Cleared Nov 22, 1995
CASPER
K953227 · IXI
Northwest Medical Physics Center
Radiology · 140d
Cleared Nov 22, 1995
CP 100/30
K953292 · IZL
Micro-Focus Imaging., Inc.
Radiology · 132d
Cleared Nov 22, 1995
VARICAM
K953801 · KPS
Elscint, Inc.
Radiology · 103d
Cleared Nov 22, 1995
HP ECHO IMAGE MANAGEMENT SYSTEM
K954668 · LLZ
Hewlett-Packard Co.
Radiology · 43d
Cleared Nov 21, 1995
FLOSCOPE SUPER VASCULAR LAB
K943200 · JAF
Advance Medical Device, Inc.
Radiology · 504d
Cleared Nov 21, 1995
SIEMENS Q4000
K945072 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 400d
Cleared Nov 20, 1995
LEKSELL GAMMA UNIT MODEL 23004,TYPE B.
K924849 · IWB
Elekta Radiosurgery, Inc.
Radiology · 1148d
Cleared Nov 20, 1995
HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100
K945400 · IZI
Hitachi Medical Corp. of America
Radiology · 382d
Cleared Nov 20, 1995
MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
K954190 · MOS
Medical Advances, Inc.
Radiology · 75d
Cleared Nov 20, 1995
MAX-1000A/R1
K954590 · JAA
Toshiba America Medical Systems, In.C
Radiology · 49d
Cleared Nov 14, 1995
PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)
K940001 · IYE
Nucletron Corp.
Radiology · 680d