510(k) Report

FDA applicant

Invia

Ashland, MA3 decisions2008–20260 recalls

FDA records 3 decisions for Invia (Ashland, MA) from 2008 to 2026: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KPS (System, Tomography, Computed, Emission). Its devices cite 8 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “INVIA, LLC”.

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 Invia’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12010: 12026 (partial year): 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Invia by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Invia’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?

  • LLZSystem, Image Processing, Radiological1decision
  • KPSSystem, Tomography, Computed, Emission1decision
  • QIHAutomated Radiological Image Processing Software1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K101279CORRIDOR4DM V2010 Model: V2010Invia · 20104cite it
  • K080575CORRIDOR4DMInvia · 20082cite it

What has FDA decided for it lately?

  • K2608794DMInvia, LLC · 2026
  • K101279CORRIDOR4DM V2010 Model: V2010Invia · 2010
  • K080575CORRIDOR4DMInvia · 2008

All 2 as Invia →The one decision as Invia, LLC →