510(k) Report

FDA applicant

Mitra Imaging, Inc.

San Leandro, CA3 decisions1997–19981 recall

FDA records 3 decisions for Mitra Imaging, Inc. (San Leandro, CA) from 1997 to 1998: 3 510(k) clearances. Most are in product codes LMD (System, Digital Image Communications…) and LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Mitra Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mitra Imaging, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • LMDSystem, Digital Image Communications, Radiological2decisions
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K970652Mitra Imaging, Inc. Film Express Scanning SoftwareMitra Imaging, Inc. · 19971cites it
  • K974102Miltra Imaging Inc., Image VaultMitra Imaging, Inc. · 19981cites it
  • K982769Mitra Imaging Inc. ExhibitMitra Imaging, Inc. · 19981cites it

What has FDA decided for it lately?

  • K982769Mitra Imaging Inc. ExhibitMitra Imaging, Inc. · 19981 recall
  • K974102Miltra Imaging Inc., Image VaultMitra Imaging, Inc. · 1998
  • K970652Mitra Imaging, Inc. Film Express Scanning SoftwareMitra Imaging, Inc. · 1997

All 3 as Mitra Imaging, Inc. →

What has been recalled?

1 recall linked to its devices; the latest: