510(k) Report

FDA applicant

Iray Imaging Technology (Haining) Limited

Haining, CN4 decisions2023–20250 recalls

FDA records 4 decisions for Iray Imaging Technology (Haining) Limited (Haining, CN) from 2023 to 2025: 4 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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, dental panel, where it files most

How often FDA has decided Iray Imaging Technology (Haining) Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2023: 22025: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Iray Imaging Technology (Haining) Limited by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Iray Imaging Technology (Haining)…’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?

  • MUHSystem, X-Ray, Extraoral Source, Digital2decisions
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 74 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 92 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 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.

  • K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited · 20252cite it

What has FDA decided for it lately?

  • K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited · 2025
  • K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited · 2025
  • K230998Digital Wireless Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited · 2023
  • K230811Digital Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited · 2023

All 4 as Iray Imaging Technology (Haining) Limited →

Other applicant names beginning “Iray”

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

Iray Technology Taicang, Ltd. 21Iray Technology (Shanghai), Ltd. 1