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
11305–11328 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 27, 1995
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K953595 · MOS
GE Medical Systems
Radiology · 88d
Cleared Oct 27, 1995
REDI-VU SYSTEMS (SEND & RECEIVE)
K954008 · LMD
Jd Technical Services, Inc.
Radiology · 63d
Cleared Oct 27, 1995
EXPLOR-X (AZTEH) HF
K954565 · EAP
Chicago X-Ray Systems, Inc.
Radiology · 25d
Cleared Oct 25, 1995
CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
K945838 · KPQ
Toshiba America Medical Systems, In.C
Radiology · 330d
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