FDA product code IYH: Generator, Dermatological (Grenz Ray), Therapeutic X-Ray

IYH is the FDA product code for generator, dermatological (grenz ray), 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 IYH. The average 510(k) review took 56 days (median 56). FDA has posted 1 recall for IYH devices.

Classification

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

Top IYH applicants

Most recent IYH clearances

Recalls for IYH devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-03-06.

Frequently asked questions

What is FDA product code IYH?

IYH is the FDA product code for generator, dermatological (grenz ray), 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 IYH?

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

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

Across 1 cleared submissions the average was 56 days from receipt to decision (median 56).

Which companies have the most IYH clearances?

X-Cel X-Ray Corp. (1).

Have IYH devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2015-03-06.

Next steps

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