510(k) clearances

QuickRad

Aikenist Technologies Pvt, Ltd. · Radiology

K242838Substantially EquivalentTraditionalLLZ
Open FDA's page for this record
Third party flag
N
City
Bengaluru
Advisory committee description
Radiology
Address 1
15/A, 2nd Floor, 10th Main, 22nd Cross
Address 2
3rd Block, Jayanagar
Statement or summary
Summary
Product code
LLZ
Zip code
560011
Applicant
Aikenist Technologies Pvt, Ltd.
Decision date
2025-02-21
Decision code
SESE
Country code
IN
Device name
QuickRad
Advisory committee
RA
Contact
Ashwin Amarapuram Chandramouly
K number
K242838
Date received
2024-09-19
Review advisory committee
RA
Postal code
560011
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.