510(k) Report

FDA applicant

See-Mode Technologies Pte, Ltd.

Singapore, SG3 decisions2020–20260 recalls

FDA records 3 decisions for See-Mode Technologies Pte, Ltd. (Singapore, SG) from 2020 to 2026: 3 510(k) clearances. Most are in product codes QDQ (Radiological Computer Assisted…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 179 days from receipt to decision, against 153 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.

FDA’s records also spell it “See-Mode Technologies Pty, Ltd.”.

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 See-Mode Technologies Pte, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12024: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — See-Mode Technologies Pte, Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For…2decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 179 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 153 days; 0 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:

What has FDA decided for it lately?

  • K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd. · 2026
  • K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd. · 2024
  • K201369AVA (Augmented Vascular Analysis)See-Mode Technologies Pte, Ltd. · 2020

All 2 as See-Mode Technologies Pte, Ltd. →The one decision as See-Mode Technologies Pty, Ltd. →