FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
10609–10632 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 28, 1997
ARTOSCAN M
K963262 · LNH
Biosound, Inc.
Radiology · 220d
Cleared Mar 28, 1997
GYREX 2T-PRESTIGE
K970005 · LNI
Elscint, Inc.
Radiology · 85d
Cleared Mar 26, 1997
LEVEL 10 HDI
K961459 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 344d
Cleared Mar 26, 1997
DOCTORS REVIEW SYSTEM
K970402 · LLZ
Digisonics, Inc.
Radiology · 51d
Cleared Mar 21, 1997
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
K962010 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 302d
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