510(k) Report

FDA applicant

Smart Soft Healthcare AD

Varna, BG3 decisions2022–20260 recalls

FDA records 3 decisions for Smart Soft Healthcare AD (Varna, BG) from 2022 to 2026: 3 510(k) clearances. All are in product code QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 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 Smart Soft Healthcare AD’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Smart Soft Healthcare AD by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 107 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K220497CoLumboSmart Soft Healthcare AD · 20224cite it

What has FDA decided for it lately?

  • K254015CoLumbo C-SpineSmart Soft Healthcare AD · 2026
  • K250367CoLumboXSmart Soft Healthcare AD · 2025
  • K220497CoLumboSmart Soft Healthcare AD · 2022

All 3 as Smart Soft Healthcare AD →