510(k) Report

FDA applicant

Heartvista, Inc.

Los Altos, CA6 decisions2014–20210 recalls

FDA records 6 decisions for Heartvista, Inc. (Los Altos, CA) from 2014 to 2021: 6 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 185 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Heartvista, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 22016: 12017: 12019: 12021: 1
2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Heartvista, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heartvista, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging6decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 185 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 93 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K153740RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 20161cites it
  • K183274RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 20191cites it
  • K212233RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 20211cites it
  • K170090RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 20171cites it
  • K142997RTHawk, HeartVista Workstation with RTHawkHeartvista, Inc. · 20141cites it
  • K133848Rthawk, Rthawk, or Heartvista Workstation with RthawkHeartvista, Inc. · 20141cites it

What has FDA decided for it lately?

  • K212233RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2021
  • K183274RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2019
  • K170090RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2017
  • K153740RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2016
  • K142997RTHawk, HeartVista Workstation with RTHawkHeartvista, Inc. · 2014
  • K133848Rthawk, Rthawk, or Heartvista Workstation with RthawkHeartvista, Inc. · 2014

All 6 as Heartvista, Inc. →