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
8737–8760 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 04, 2003
HTS COIL
K022863 · MOS
Jockey Club Mri Engineering Center
Radiology · 160d
Cleared Feb 04, 2003
GE DISCOVERY LS SYSTEM
K023988 · KPS
GE Medical Systems
Radiology · 64d
Cleared Feb 04, 2003
PANORAMA ENHANCEMENTS
K024042 · LNH
Philips Medical Systems, Inc.
Radiology · 60d
Cleared Feb 04, 2003
INFINION SOFTWARE FEATURES
K024066 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 57d
Cleared Feb 04, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K024187 · MOS
Usa Instruments, Inc.
Radiology · 47d
Cleared Feb 04, 2003
UP-DF500 FILMSTATION DIGITAL FILM IMAGER
K024188 · LMC
Sony Medical Systems
Radiology · 47d
Cleared Jan 31, 2003
RADIOMED MARKER
K022326 · JAK
Radiomed Corporation
Radiology · 197d
Cleared Jan 31, 2003
RTDOSEPLAN
K022961 · MUJ
Math Resolutions, LLC
Radiology · 147d
Cleared Jan 29, 2003
AURORA MR-GUIDED INTERVENTIONAL SYSTEM
K023686 · LNH
Aurora Imaging Technology, Inc.
Radiology · 89d
Cleared Jan 29, 2003
TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
K030191 · IYN
Teratech Corp.
Radiology · 8d
Cleared Jan 24, 2003
PICUS ULTRASOUND IMAGING SYSTEMS
K023512 · IYN
Pie Medical
Radiology · 95d
Cleared Jan 24, 2003
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
K023650 · MOS
Usa Instruments, Inc.
Radiology · 86d
Cleared Jan 24, 2003
QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
K023970 · IZI
Medis Medical Imaging Systems BV
Radiology · 56d
Cleared Jan 24, 2003
SHARP VIEW IMAGE ENHANCEMENT SYSTEM
K024028 · LLZ
Context Vision AB
Radiology · 49d
Cleared Jan 24, 2003
IVUS PLUS
K024103 · LLZ
Indec Systems, Inc.
Radiology · 43d
Cleared Jan 23, 2003
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
K023613 · IXW
Alphatek Corp.
Radiology · 87d
Cleared Jan 22, 2003
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
K030064 · ITX
Sonosite,Inc.
Radiology · 15d
Cleared Jan 17, 2003
BARCO MEDIS 5MP2 AURA
K023533 · LLZ
Barco N.V.
Radiology · 88d
Cleared Jan 17, 2003
ULTRASOUND SCANNER, TYPE 2400
K024236 · IYN
B & K Medical A/S
Radiology · 25d
Cleared Jan 16, 2003
RADIONICS VARILINK 2
K023519 · IYE
Radionics, A Division of Tyco...
Radiology · 87d
Cleared Jan 16, 2003
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
K024200 · OWB
Ge Medical Systems, Inc.
Radiology · 27d
Cleared Jan 15, 2003
JUPITER PROCESSING AND REVIEW WORKSTATION
K024137 · LLZ
Ge Medical Systems, Inc.
Radiology · 30d
Cleared Jan 13, 2003
NON-INVASIVE PATIENT FIXATION SYSTEM
K023449 · IYE
Stryker Leibinger
Radiology · 90d
Cleared Jan 10, 2003
A-SCAN 100
K024114 · IYO
Ophthalmic Technologies, Inc.
Radiology · 28d