510(k) Report

FDA applicant

Dr Systems, Inc.

San Diego, CA2 decisions2004–20156 recalls

FDA records 2 decisions for Dr Systems, Inc. (San Diego, CA) from 2004 to 2015: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 4 predicates, 0 of them its own earlier devices. 6 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 Dr Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2017

2015: 22016: 22017: 2
2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Dr Systems, 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?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K041935DR Systems Pacs, Release 6.1Dr Systems, Inc. · 20041cites it
  • K143318DR Systems Zero Download 3D Viewer (Z3D)Dr Systems, Inc. · 20151cites it

What has FDA decided for it lately?

  • K143318DR Systems Zero Download 3D Viewer (Z3D)Dr Systems, Inc. · 20152 recalls
  • K041935DR Systems Pacs, Release 6.1Dr Systems, Inc. · 20046 recalls

All 2 as Dr Systems, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K041935Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on…Aug 14, 2017Class II
  • K143318Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on…Aug 7, 2017Class II
  • K041935DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge…Apr 8, 2016Class II
  • K041935DR Systems Unity PACS software, now known as Merge Unity PACSApr 8, 2016Class II
  • K041935DR Systems Unity PACS software, now known as Merge Unity PACS software.Oct 15, 2015Class II
  • K041935Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image…Jul 23, 2015Class II