510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243065Substantially Equivalent

Cardiac Guidance

Caption Health, San Mateo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243065 is the FDA 510(k) clearance record for Cardiac Guidance, a class II device, cleared for Caption Health, Inc. on under FDA product code QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence). FDA's definition for product code QJU reads: "A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its...". FDA records list 6 510(k) clearances for Caption Health, Inc., from to . As of , FDA records show no recalls naming K243065.

Clearance record

Decision date
Received
(110 days to decision)
Product code
QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Regulation
21 CFR 892.2100
Device class
Class II
Review panel
Radiology
Applicant
Caption Health, Inc. 4 W. 4th Ave., San Mateo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJU

Trailing 12 months
3 clearances under product code QJU in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QJU, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260