FDA product code · Radiology

Collimator, High Voltage, Therapeutic X-Ray

Name: FDA decisions, review times, recalls and adverse event reports for product code IYK
Creator: 510(k) Report

IYKClass II21 CFR 892.5900510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, radiology panel

Twenty years of IYK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — IYK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IYK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 892.5900.

IYC Generator, Orthovoltage, Therapeutic X-Ray IYD Generator, Low Voltage, Therapeutic X-Ray IYI Collimator, Orthovoltage, Therapeutic X-Ray IYH Generator, Dermatological (Grenz Ray)…KPZ Generator, High Voltage, X-Ray, Therapeutic IYJ Collimator, Low Voltage, Therapeutic X-Ray IYL Collimator, Dermatological, Therapeutic X-Ray JAD System, Therapeutic, X-Ray KQA Device, Beam Limiting, X-Ray, Therapeutic