FDA applicant
Iray Technology Taicang, Ltd.
FDA records 21 decisions for Iray Technology Taicang, Ltd. (Taicang, CN) from 2018 to 2023: 21 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and MUH (System, X-Ray, Extraoral Source, Digital). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 48 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 16 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Iray Technology Taicang, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
2in 2020
Class I Class II/III not classified
Planning a device like Iray Technology Taicang, Ltd.’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) ReportOther applicant names beginning “Iray”
FDA records each applicant name separately; these may or may not be the same firm.