510(k) Report

FDA applicant

Skanray Technologies Private Limited

Mysore, IN4 decisions2016–20170 recalls

FDA records 4 decisions for Skanray Technologies Private Limited (Mysore, IN) from 2016 to 2017: 4 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 193 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 0 of them its own earlier devices. No 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, cardiovascular panel, where it files most

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

FDA decisions per year

2in 2017

2016: 22017: 2
2016high 2 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Skanray Technologies Private Limited by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile1decision
  • EHDUnit, X-Ray, Extraoral With Timer1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 193 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 101 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K170946Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V VariantSkanray Technologies Private Limited · 20171cites it

What has FDA decided for it lately?

  • K170946Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V VariantSkanray Technologies Private Limited · 2017
  • K170967Intraskan DC PlusSkanray Technologies Private Limited · 2017
  • K152831Spot SkanSkanray Technologies Private Limited · 2016
  • K151512Star 60Skanray Technologies Private Limited · 2016

All 4 as Skanray Technologies Private Limited →

Other applicant names beginning “Skanray”

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

Skanray Technologies Limited 6Skanray Technologies Pvt, Ltd. 2