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510(k) K212494

Lung Image Analysis by Pulmonx Corporation — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2021
Date Received
August 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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  • K252217 — CT VScore+ (November 28, 2025)
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  • K250766 — LungQ 4 (October 2, 2025)