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
7873–7896 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 14, 2005
19-INCH (48CM) COLOR LCD MONITOR CDL1904A
K051403 · LLZ
Totoku Electric Co., Ltd.
Radiology · 44d
Cleared Jul 14, 2005
ECHOSYSTEM
K051745 · LLZ
Medstrat, Inc.
Radiology · 15d
Cleared Jul 14, 2005
QD KNEE/FOOT COIL, MODEL MJQJ-147A
K051763 · MOS
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jul 14, 2005
CERETOM, MODEL NL3000
K051765 · JAK
Neurologica Corporation
Radiology · 14d
Cleared Jul 14, 2005
NOMAD DENTAL X-RAY SYSTEM
K051795 · EHD
Aribex, Inc.
Radiology · 9d
Cleared Jul 13, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K051549 · KPS
Digirad Corp.
Radiology · 30d
Cleared Jul 07, 2005
GE OEC EVERVIEW 7500
K051490 · OXO
Ge Oec Medical Systems, Inc.
Radiology · 31d
Cleared Jul 07, 2005
FUJI SYNAPSE WORKSTATION SOFTWARE
K051553 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 24d
Cleared Jul 07, 2005
AXIOM SIRESKOP SD
K051602 · JAA
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Jul 01, 2005
INSTANT-X, MODELS 1713 & 128
K042791 · MQB
Ann Arbor Digital Devices
Radiology · 267d
Cleared Jul 01, 2005
NAVIGATOR
K042875 · IYE
Nomos Corp.
Radiology · 256d
Cleared Jul 01, 2005
SMITH & NEPHEW CDS SYSTEM
K051136 · JAA
Smith & Nephew, Inc.
Radiology · 58d
Cleared Jul 01, 2005
DIRECT DIGITIZER REGIUS MODEL 370
K051418 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 30d
Cleared Jul 01, 2005
MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
K051423 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 30d
Cleared Jul 01, 2005
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
K051541 · FDF
Olympus America, Inc.
Radiology · 21d
Cleared Jun 29, 2005
BTI-SCAN, VERSION 4.0
K051392 · LLZ
B.T.I. Biotechnology Institute, Sl.
Radiology · 33d
Cleared Jun 28, 2005
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
K050728 · MOS
Usa Instruments, Inc.
Radiology · 99d
Cleared Jun 28, 2005
IMAGEQUBE PACS
K051037 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 64d
Cleared Jun 28, 2005
CAC-127-8 CARDOAC ARRAY COIL
K051512 · MOS
Invivo Corp.
Radiology · 21d
Cleared Jun 28, 2005
REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION
K051521 · LLZ
Konica Minolta Medical & Graphic, Inc.
Radiology · 20d
Cleared Jun 27, 2005
19-INCH (48 CM) COLOR LCD MONITOR CDL1902A
K051331 · LLZ
Totoku Electric Co., Ltd.
Radiology · 35d
Cleared Jun 24, 2005
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
K051464 · EHD
Planmeca Oy
Radiology · 21d
Cleared Jun 23, 2005
3.0T PROSTATE IMAGING SYSTEM
K051349 · MOS
Medrad, Inc.
Radiology · 30d
Cleared Jun 21, 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · MQB
Eastman Kodak Company
Radiology · 15d