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Manufacturers
CA
Imeka Solutions, Inc.
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Medical Device Manufacturer
·
CA , Sherbrooke
Imeka Solutions, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
Recent clearances:
ANDI 2.2
,
ANDI 2.0
,
ANDI
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Imeka Solutions, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
May 28, 2026
ANDI 2.2
K261405
·
QIH
Radiology
·
29d
Cleared
Oct 22, 2025
ANDI 2.0
K252298
·
QIH
Radiology
·
91d
Cleared
Jul 25, 2023
ANDI
K230913
·
QIH
Radiology
·
116d
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3
Radiology
3