510(k) clearances

VUZE System

Vuze Medical , Ltd. · Radiology

K232976Substantially EquivalentTraditionalLLZ
Open FDA's page for this record
Third party flag
N
City
Tel Aviv
Advisory committee description
Radiology
Address 1
3/84 Rav Ashi St.
Statement or summary
Summary
Product code
LLZ
Zip code
6939537
Applicant
Vuze Medical , Ltd.
Decision date
2024-05-09
Decision code
SESE
Country code
IL
Device name
VUZE System
Advisory committee
RA
Contact
David Tolkowsky
K number
K232976
Date received
2023-09-21
Review advisory committee
RA
Postal code
6939537
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Image Processing, Radiological
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3001052305, 3005406110, 3017545364, 3005172103, 9617978, 3004706313, 3008487708, 1226544, 3009341091, 3044776706, 3010656400, 3038189169, 3007362683, 3007993775, 1061158, 3014232555, 3003757027, 3014991167, 9617592, 3013634985, 3023217364, 1054415, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 8020825, 3011676026, 3008364043, 3045521711, 3014635169, 2954921, 9615439, 3011015597, 3003989064, 3035371452, 3019544554 +603 more
FEI number
3001052305, 3005406110, 3017545364, 3005172103, 3004706313, 3008487708, 3009341091, 3044776706, 3002808188, 3010656400, 3038189169, 3007362683, 3007993775, 3014232555, 3003757027, 3014991167, 3013634985, 3023217364, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 3011676026, 3008364043, 3045521711, 3014635169, 3011015597, 3003989064, 3035371452, 3019544554, 3008548323, 3014269683, 3002821504, 2126677, 3002619595, 3010684280, 3003861317 +603 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.