510(k) Report

FDA applicant

Heartlab, Inc.

Westerly, RI6 decisions1995–200524 recalls

FDA records 6 decisions for Heartlab, Inc. (Westerly, RI) from 1995 to 2005: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 10 predicates, 1 of them its own earlier devices. 24 recalls are 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 Heartlab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heartlab, Inc. since 2007.

Recalls per year

1in 2016

2007: 42008: 32009: 22010: 12011: 62012: 32013: 22014: 12015: 12016: 1
2007high 6 (2011) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Heartlab, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological4decisions
  • LMDSystem, Digital Image Communications, Radiological1decision
  • DPSElectrocardiograph1decision

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K050228Agfa Heartlab CardiovascularHeartlab, Inc. · 20052cite it
  • K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 20052cite it
  • K954479DicomviewHeartlab, Inc. · 19961cites it
  • K040896Modification to EncompassHeartlab, Inc. · 20041cites it
  • K954860EchonetHeartlab, Inc. · 19951cites it

What has FDA decided for it lately?

  • K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 20051 recall
  • K050228Agfa Heartlab CardiovascularHeartlab, Inc. · 200522 recalls
  • K042042Ultrasound Capture SystemHeartlab, Inc. · 2004
  • K040896Modification to EncompassHeartlab, Inc. · 20041 recall
  • K954479DicomviewHeartlab, Inc. · 1996
  • K954860EchonetHeartlab, Inc. · 1995

All 6 as Heartlab, Inc. →

What has been recalled?

24 recalls linked to its devices; the latest:

  • K050228IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical…Dec 22, 2016Class II
  • K050228IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV…Sep 1, 2015Class II
  • K050228IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical…Apr 30, 2014Class II
  • K050228IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting.…Mar 15, 2013Class II
  • K050228IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick…Mar 15, 2013Class II
  • K050228AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with…Aug 9, 2012Class II