510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241891Substantially Equivalent

ScreenDx

Imvaria, Berkeley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241891 is the FDA 510(k) clearance record for ScreenDx, a class II device, cleared for Imvaria, Inc. on under FDA product code QWO (Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.). FDA's definition for product code QWO reads: "Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of...". FDA records list 3 510(k) clearances for Imvaria, Inc., from to . As of , FDA records show no recalls naming K241891.

Clearance record

Decision date
Received
(196 days to decision)
Product code
QWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Regulation
21 CFR 892.2085
Device class
Class II
Review panel
Radiology
Applicant
Imvaria, Inc. 2930 Domingo Ave. #1496, Berkeley CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QWO

Trailing 12 months
1 clearance under product code QWO in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QWO, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260