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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
9961–9984 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 02, 1999
GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER,...
K991236 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 51d
Cleared Jun 01, 1999
SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
K991302 · IXC
Smartlight, Inc.
Radiology · 46d
Cleared May 28, 1999
DPD-12PCC
K990734 · IYE
Scanditronix Medical AB
Radiology · 84d
Cleared May 27, 1999
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K990753 · JAQ
Cook, Inc.
Radiology · 80d
Cleared May 27, 1999
E-SCAN
K990968 · LNH
Biosound Esaote, Inc.
Radiology · 65d
Cleared May 24, 1999
HITACHI VERSIFLEX
K991231 · IZI
Hitachi Medical Systems America, Inc.
Radiology · 42d
Cleared May 21, 1999
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
K984328 · IWB
Elekta Instrument AB
Radiology · 169d
Cleared May 20, 1999
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K990193 · KXK
Implant Sciences Corp.
Radiology · 119d
Cleared May 20, 1999
LIFE IMAGING SYSTEMS, MODEL L3DI
K990560 · IYO
Life Imaging Systems, Inc.
Radiology · 87d
Cleared May 20, 1999
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
K991057 · MOS
Toshiba America Mri, Inc.
Radiology · 51d
Cleared May 20, 1999
AII-PRO 100 PLUS AND ALL-PRO 200
K991435 · IXW
All-Pro Imaging Corp.
Radiology · 24d
Cleared May 19, 1999
OSTEOGRAM BONE DENSITOMETER
K984285 · KGI
Compumed, Inc.
Radiology · 169d
Cleared May 14, 1999
EXCELART
K990620 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared May 13, 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226 · KXK
Uromed Corp.
Radiology · 323d
Cleared May 13, 1999
DMD DIGITAL X-RAY SYSTEM
K990087 · MUH
Dental/Medical Diagnostic Systems, Inc.
Radiology · 122d
Cleared May 13, 1999
HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
K991129 · KPS
Hitachi Medical Corp. of America
Radiology · 41d
Cleared May 13, 1999
PHILIPS TOMOSCAN AV-NT
K991278 · JAK
Philips Medical Systems North...
Radiology · 29d
Cleared May 12, 1999
ROCS ULTRASEED
K984241 · IYE
Radiation Oncology Computer Systems
Radiology · 166d
Cleared May 12, 1999
CALCIUM SCORING
K990426 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared May 12, 1999
PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION
K990455 · LLZ
Philips Medical Systems, Inc.
Radiology · 89d
Cleared May 11, 1999
ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
K990442 · LLZ
Vital Images, Inc.
Radiology · 90d
Cleared May 11, 1999
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K990550 · LNH
Ge Medical Systems, Inc.
Radiology · 78d
Cleared May 05, 1999
SCANFLEX SOLID COUPLANT MEMBRANE
K983691 · ITX
Sonotech, Inc.
Radiology · 197d
Cleared May 05, 1999
CTS-310(B)
K984161 · IYO
Shantou Institute of Ultrasonic...
Radiology · 166d