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
10633–10656 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 04, 1997
MD-1835
K964806 · IXL
Fischer Imaging Corp.
Radiology · 95d
Cleared Mar 04, 1997
PHASED ARRAY TRANSDUCER - - PSK-20CT
K970047 · ITX
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Feb 28, 1997
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
K964820 · MOS
Us Asia Instruments, Inc.
Radiology · 88d
Cleared Feb 28, 1997
ISOCAM II (DUAL HEAD GAMMA CAMERA)
K964834 · KPS
Park Medical Systems, Inc.
Radiology · 88d
Cleared Feb 26, 1997
UHE COLLIMATOR (210591)
K963406 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 181d
Cleared Feb 26, 1997
VIPOR UNIT
K964322 · JAA
Tilane Corp.
Radiology · 120d
Cleared Feb 26, 1997
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER...
K964813 · MOS
Medical Advances, Inc.
Radiology · 89d
Cleared Feb 26, 1997
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
K964990 · JAA
Hitachi Medical Systems America, Inc.
Radiology · 72d
Cleared Feb 26, 1997
PM 2002 CC PROLINE
K970263 · EHD
Planmeca Oy
Radiology · 34d
Cleared Feb 24, 1997
KINEMATIC POSITIONING DEVICES
K964752 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 89d
Cleared Feb 24, 1997
HI-STAR MRI IMAGING SYSTEM
K964778 · LNH
Health Images, Inc.
Radiology · 89d
Cleared Feb 21, 1997
RHEO DOPPLEX II (RD 2)
K964699 · IYN
Huntleigh Technology, Inc.
Radiology · 88d
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