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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,520 results
11161–11184 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 25, 1995
XKNIFE-3
K953482 · IYE
Radionics Software Applications, Inc.
Radiology · 93d
Cleared Oct 25, 1995
PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)
K953570 · IYE
Philips Medical Systems, Inc.
Radiology · 86d
Cleared Oct 24, 1995
SCINTRON IV
K953193 · KPS
Medical Imaging Electronics America,...
Radiology · 106d
Cleared Oct 24, 1995
NUQUEST NUCLEAR MEDICINE COMPUTER
K953255 · KPS
Sitco, Inc.
Radiology · 104d
Cleared Oct 24, 1995
ULTRASOUND PROBE BIOPSY ACCESSORIES
K953430 · ITX
Biosound, Inc.
Radiology · 95d
Cleared Oct 24, 1995
SIENET SPI SPOOLER
K953552 · LMD
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Oct 24, 1995
HDX DIGITAL IMAGING SYSTEM
K954055 · LLZ
Imacom, Inc.
Radiology · 56d
Cleared Oct 24, 1995
UNIVERSIX 120
K954196 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 48d
Cleared Oct 24, 1995
MAMMOSPOT PADDLE
K954521 · IZH
American Mammographics, Inc.
Radiology · 26d
Cleared Oct 23, 1995
LUNAR DPX DENSITOMETER
K953032 · KGI
Lunar Corp.
Radiology · 115d
Cleared Oct 23, 1995
IRIS BILATERAL TMJ
K953248 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Oct 23, 1995
CENTRALITE BACKPOINTER
K954414 · IWE
Diacor, Inc.
Radiology · 32d
Cleared Oct 19, 1995
DPX TISSUE QUANTIFICATION OUTPUT
K935454 · JAK
Lunar Corp.
Radiology · 706d
Cleared Oct 18, 1995
BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS
K945983 · KXK
Bebig Trade, Inc.
Radiology · 314d
Cleared Oct 18, 1995
LUMISYS DICOM TOOKLIT
K953371 · LMD
Lumisys, Inc.
Radiology · 92d
Cleared Oct 18, 1995
PHILIPS BV 300 SERIES
K953910 · OXO
Philips Medical Systems North...
Radiology · 58d
Cleared Oct 18, 1995
BLA-800A
K954310 · KPW
Toshiba Medical Systems
Radiology · 33d
Cleared Oct 18, 1995
DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR
K954345 · IXW
Doosan Corp.
Radiology · 30d
Cleared Oct 18, 1995
KODAK AUTOMIXER II PLUS
K954484 · IXW
Eastman Kodak Company
Radiology · 21d
Cleared Oct 17, 1995
QD BILATERAL BREAST COIL
K953262 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 96d
Cleared Oct 17, 1995
SONOGEL
K953468 · IYO
Sonotech, Inc.
Radiology · 85d
Cleared Oct 13, 1995
REGULUS MEASUREMENT UNIT
K935456 · HAW
Compass Intl., Inc.
Radiology · 700d
Cleared Oct 07, 1995
MAGNETOM VISION (PROJECT 016)
K945517 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 332d
Cleared Oct 07, 1995
UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT...
K951764 · IYE
Ptw-New York Corp.
Radiology · 173d