510(k) Report

FDA applicant

Skanray Technologies Limited

Mysore, IN6 decisions2011–20250 recalls

FDA records 6 decisions for Skanray Technologies Limited (Mysore, IN) from 2011 to 2025: 6 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 152 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Skanray Technologies”.

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 Skanray Technologies Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011: 22022: 22023: 12025: 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Skanray Technologies Limited by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Skanray Technologies Limited’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?

  • EHDUnit, X-Ray, Extraoral With Timer2decisions
  • KPRSystem, X-Ray, Stationary2decisions
  • IZLSystem, X-Ray, Mobile1decision
  • OWBInterventional Fluoroscopic X-Ray System1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 152 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K111330Air Techniques High Frequency Intra-Oral X-RaySkanray Technologies · 20111cites it
  • K103579Intra Skan DCSkanray Technologies · 20111cites it

What has FDA decided for it lately?

  • K251893Skan C PulsarSkanray Technologies Limited · 2025
  • K231761PodSKAN HF Diagnostic X-ray SystemSkanray Technologies Limited · 2023
  • K220518Skanrad 400Skanray Technologies Limited · 2022
  • K212940Skanmobile, Skanmobile-DrSkanray Technologies Limited · 2022
  • K111330Air Techniques High Frequency Intra-Oral X-RaySkanray Technologies · 2011
  • K103579Intra Skan DCSkanray Technologies · 2011

All 4 as Skanray Technologies Limited →All 2 as Skanray Technologies →

Other applicant names beginning “Skanray”

FDA records each applicant name separately; these may or may not be the same firm.

Skanray Technologies Private Limited 4Skanray Technologies Pvt, Ltd. 2