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
10801–10824 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 21, 1997
PRISM XPVT SYSTEM (210823)
K964712 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 19, 1997
COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER
K940942 · IYO
Medison America, Inc.
Radiology · 1086d
Cleared Feb 19, 1997
ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
K961073 · IYO
Atlantis Diagnostics Intl., Inc.
Radiology · 338d
Cleared Feb 18, 1997
MODELS EXL AND EXS EXTREMITY COIL SET
K964668 · MOS
Mri Devices Corp.
Radiology · 89d
Cleared Feb 14, 1997
OASIS
K964658 · ITX
Sonotech, Inc.
Radiology · 86d
Cleared Feb 11, 1997
ULTRASOUND SYSTEM MODEL UF-3500
K955543 · IYO
Fukuda Denshi USA, Inc.
Radiology · 434d
Cleared Feb 11, 1997
PHASED ARRAY NECK COIL
K964678 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 82d
Cleared Feb 11, 1997
THE NOMOS MINICRANE
K964740 · JAI
Nomos Corp.
Radiology · 77d
Cleared Feb 11, 1997
MATRIX 3000 FLEXIBLE SPINE COIL
K964753 · LNH
Us Asia Instruments, Inc.
Radiology · 76d
Cleared Feb 11, 1997
UNIVISION ECHOCARDIOLOGY SYSTEM
K964803 · LMB
Network Concepts, Inc.
Radiology · 74d
Cleared Feb 11, 1997
BEAM BLOCK TRAYS
K964840 · IYE
Aktina Medical Physics Corp.
Radiology · 74d
Cleared Feb 11, 1997
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
K964854 · MOS
Medrad, Inc.
Radiology · 70d
Cleared Feb 10, 1997
GAMMA GUIDANCE SYSTEM
K961321 · IZD
Radiation Monitoring Devices, Inc.
Radiology · 311d
Cleared Feb 10, 1997
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
K961974 · ITX
Pentax Precision Instrument Corp.
Radiology · 266d
Cleared Feb 10, 1997
PROTEC (1024)
K963730 · KPS
Proportional Technologies, Inc.
Radiology · 147d
Cleared Feb 10, 1997
SHEATHES (NON-LATEX)
K963831 · ITX
Medical Resources
Radiology · 139d
Cleared Feb 10, 1997
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
K964626 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 83d
Cleared Feb 10, 1997
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647 · KXK
North American Scientific, Inc.
Radiology · 82d
Cleared Feb 10, 1997
SOMATOM PLUS 4 CT SCANNER
K964747 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Feb 07, 1997
ULTRASOUND GASTROSCOPE GF TYPE UM30P
K963023 · FDS
Olympus America, Inc.
Radiology · 186d
Cleared Feb 06, 1997
MLC FIT
K962335 · IYE
Impac Medical Systems, Inc.
Radiology · 234d
Cleared Feb 06, 1997
TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
K963302 · ITX
Tayman Medical, Inc.
Radiology · 168d
Cleared Feb 05, 1997
PLANNED SOPHIED CLASSIC
K962105 · IZH
Planmed OY
Radiology · 250d
Cleared Feb 04, 1997
PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
K964485 · IYE
Eliav , Ltd.
Radiology · 88d