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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
13585–13608 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 06, 1989
MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884676 · IZH
Elscint, Inc.
Radiology · 59d
Cleared Jan 06, 1989
MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884677 · IZH
Elscint, Inc.
Radiology · 59d
Cleared Jan 04, 1989
ONCOPROBE SYSTEM
K884770 · IZD
Care Wise Medical Products Corp.
Radiology · 51d
Cleared Jan 03, 1989
OPHTHASCAN MINI-B
K884595 · IYO
Biophysic Medical, Inc.
Radiology · 61d
Cleared Dec 30, 1988
EXEL 905 SERIES CT SCANNER
K884667 · JAK
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
EXEL 1002 CT SCANNER
K884668 · JAK
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
EXEL 2002 & 2002FS CT SCANNER
K884669 · JAK
Elscint, Inc.
Radiology · 52d
Cleared Dec 22, 1988
ADAC VIEWPOINT (ADDITIONAL SOFTWARE)
K884349 · KPS
Adac Laboratories
Radiology · 71d
Cleared Dec 22, 1988
COMPAX MODEL 40, 400, 400T
K884930 · IZZ
General Electric Co.
Radiology · 27d
Cleared Dec 21, 1988
CMS RECORD AND VERIFY SYSTEM
K882484 · JAD
Computerized Medical Systems, Inc.
Radiology · 189d
Cleared Dec 21, 1988
VARIABLE KV INTREX VSK 60 - 90 KVP
K883354 · EAP
Keystone X-Ray, Inc.
Radiology · 134d
Cleared Dec 21, 1988
MT/S (SOFTWARE RELEASE 3.1)
K884607 · LNH
Diasonics, Inc.
Radiology · 47d
Cleared Dec 20, 1988
VOXELSCOPE(TM)
K884268 · JAK
Dynamic Digital Displays, Inc.
Radiology · 70d
Cleared Dec 20, 1988
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317 · JAA
Medrad, Inc.
Radiology · 68d
Cleared Dec 15, 1988
UROIMAGER
K883925 · IYO
Ausonics Pty , Ltd.
Radiology · 90d
Cleared Dec 14, 1988
WWDS-005 HUMAN RECTAL PROBE
K883079 · IYO
Ausonics Pty , Ltd.
Radiology · 146d
Cleared Dec 13, 1988
CFX 625
K883976 · IZO
Fischer Imaging Corp.
Radiology · 84d
Cleared Dec 12, 1988
SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K875187 · IYO
Shimadzu Corp.
Radiology · 356d
Cleared Dec 05, 1988
MT/S (SPINE TRANSMIT COIL)
K884606 · LNH
Diasonics, Inc.
Radiology · 31d
Cleared Dec 05, 1988
TEMPOROMANDIBULAR JOINT COIL (TMJ)
K884743 · LNH
Diasonics, Inc.
Radiology · 21d
Cleared Dec 01, 1988
ACUSON L538 TRANSDUCER
K883752 · IYO
Acuson Corp.
Radiology · 90d
Cleared Nov 30, 1988
GE MR MAX SYSTEM
K883547 · LNH
General Electric Co.
Radiology · 103d
Cleared Nov 30, 1988
SONY CINE VIDEO SYSTEM SME-3300
K884008 · IZI
Sony Medical Electronics Co.
Radiology · 70d
Cleared Nov 30, 1988
SHOULDER TRANSMIT AND RECEIVE COILS
K884603 · LNH
Diasonics, Inc.
Radiology · 27d