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
10849–10872 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 21, 1997
DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)
K964167 · IYE
Multidata Systems International Corp.
Radiology · 156d
Cleared Mar 21, 1997
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293 · LMD
Fujifilm Medical System U.S.A., Inc.
Radiology · 56d
Cleared Mar 21, 1997
PHILIPS EASY DIAGNOST
K970640 · IXR
Philips Medical Systems North...
Radiology · 29d
Cleared Mar 19, 1997
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
K953902 · IZH
Medical Marketing Intl., Inc.
Radiology · 579d
Cleared Mar 19, 1997
PHILIPS SONO DIAGNOST 800
K963706 · IYO
Hewlett-Packard Co.
Radiology · 184d
Cleared Mar 17, 1997
VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE
K963315 · IYO
Vingmed Sound, Inc.
Radiology · 207d
Cleared Mar 17, 1997
RADX SYSTEM
K965203 · EHD
Electro Medical Systems, Inc.
Radiology · 81d
Cleared Mar 17, 1997
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
K970034 · ITX
Hewlett-Packard Co.
Radiology · 73d
Cleared Mar 17, 1997
AMICAS WEB/INTRANET IMAGE SERVER
K970064 · LMD
Autocyt Group, Inc.
Radiology · 69d
Cleared Mar 12, 1997
CONTRAST MEDIA SET
K955179 · IZI
B.Braun Medical, Inc.
Radiology · 485d
Cleared Mar 12, 1997
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
K965161 · LMD
Sectra-Imtec AB
Radiology · 79d
Cleared Mar 12, 1997
TARGOGRID
K970037 · LNH
Daum GmbH
Radiology · 65d
Cleared Mar 11, 1997
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
K963273 · KPS
Smv America
Radiology · 203d
Cleared Mar 11, 1997
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
K965004 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Mar 11, 1997
SERIES 7600 MOBILE DIGITAL C-ARM
K970063 · OWB
Ge Dec Medical Systems
Radiology · 63d
Cleared Mar 11, 1997
DIFFUSER PANEL
K970240 · IXC
Focused Viewer, Inc.
Radiology · 48d
Cleared Mar 10, 1997
PVK-720ST ENDOCAVITARY TRANSDUCER
K964865 · ITX
Toshiba America Medical Systems, In.C
Radiology · 96d
Cleared Mar 10, 1997
AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS
K964910 · JAQ
Alpha-Omega Services, Inc.
Radiology · 91d
Cleared Mar 06, 1997
ANATOM 2000
K964890 · JAK
Analogic Corp.
Radiology · 90d
Cleared Mar 04, 1997
MD-1835
K964806 · IXL
Fischer Imaging Corp.
Radiology · 95d
Cleared Mar 04, 1997
PHASED ARRAY TRANSDUCER - - PSK-20CT
K970047 · ITX
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Feb 28, 1997
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
K964820 · MOS
Us Asia Instruments, Inc.
Radiology · 88d
Cleared Feb 28, 1997
ISOCAM II (DUAL HEAD GAMMA CAMERA)
K964834 · KPS
Park Medical Systems, Inc.
Radiology · 88d
Cleared Feb 26, 1997
UHE COLLIMATOR (210591)
K963406 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 181d