FDA product code IYD: Generator, Low Voltage, Therapeutic X-Ray

IYD is the FDA product code for generator, low voltage, therapeutic x-ray. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under IYD. The average 510(k) review took 470 days (median 470).

Classification

Compare with all 510(k) review times · Search every IYD clearance

Top IYD applicants

Most recent IYD clearances

Recalls for IYD devices

openFDA lists no recalls for product code IYD.

Frequently asked questions

What is FDA product code IYD?

IYD is the FDA product code for generator, low voltage, therapeutic x-ray. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel.

What device class is IYD?

Class II, regulation 21 CFR 892.5900. Typical premarket route: 510(k).

How long does a 510(k) take for product code IYD?

Across 1 cleared submissions the average was 470 days from receipt to decision (median 470).

Which companies have the most IYD clearances?

Toshiba America Medical Systems, In.C (1).

Next steps

• Run an FDA pathway report with predicate devices for product code IYD
• Run a recall and safety report across every IYD manufacturer
• Watch product code IYD for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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