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
10657–10680 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 01, 1997
LINAC SCALPEL FLOORSTAND
K964517 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 140d
Cleared Apr 01, 1997
UPSCAN 120
K970450 · LLZ
Merlin Engineering Works, Inc.
Radiology · 54d
Cleared Apr 01, 1997
PROSTYLE INTRA
K970975 · EHD
Planmeca Oy
Radiology · 15d
Cleared Mar 31, 1997
ACCESSPOINT, MED E-MAIL, DICOM READER
K963936 · LMB
Biosound, Inc.
Radiology · 181d
Cleared Mar 31, 1997
E. CAM PROFILE ATTENUATION CORRECTION
K963983 · KPS
Siemens Corp.
Radiology · 178d
Cleared Mar 31, 1997
FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667
K970349 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Mar 28, 1997
BIO-BINKI
K961782 · JAA
Biomni Medical Systems, Inc.
Radiology · 324d
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