510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220063Unknown

Caption Interpretation Automated Ejection Fraction Software

Caption Health, Brisbane CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220063 is the FDA 510(k) clearance record for Caption Interpretation Automated Ejection Fraction Software, a class II device, cleared for Caption Health, Inc. on under FDA product code QVD (Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan). FDA's definition for product code QVD reads: "A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The...". FDA records list 6 510(k) clearances for Caption Health, Inc., from to . As of , FDA records show no recalls naming DEN220063.

Clearance record

Decision date
Received
(149 days to decision)
Product code
QVD Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
Regulation
21 CFR 892.2055
Device class
Class II
Review panel
Radiology
Applicant
Caption Health, Inc. 2000 Sierra Pt. Pkwy., 8th Floor, Brisbane CA
Third party review
No

Clearances, product code QVD

Trailing 12 months

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

FDA records show no clearances under product code QVD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVD, 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