510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970240Substantially Equivalent

Diffuser Panel

Focused Viewer, Inc., Wauwatosa WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970240 is the FDA 510(k) clearance record for DIFFUSER PANEL, a class I device, cleared for Focused Viewer, Inc. on under FDA product code IXC (Illuminator, Radiographic-Film). FDA records list one 510(k) clearance for Focused Viewer, Inc. As of , FDA records show no recalls naming K970240.

Clearance record

Decision date
Received
(48 days to decision)
Product code
IXC Illuminator, Radiographic-Film
Regulation
21 CFR 892.1890
Device class
Class I
Review panel
Radiology
Applicant
Focused Viewer, Inc. 2420 Pasadena Blvd., Wauwatosa WI
510(k) summary
Summary
Third party review
No

Clearances, product code IXC

Trailing 12 months

FDA records hold no clearances under product code IXC in the trailing twelve months.

FDA records show no clearances under product code IXC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260