Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
A dermatological Grenz ray therapeutic X-ray generator is a device that produces very soft, low-energy X-rays used primarily for treating superficial skin conditions such as eczema, psoriasis, and other dermatoses. It is classified as FDA Class 2, indicating moderate risk and a requirement for 510(k) premarket clearance before commercial distribution. The product code is IYH, regulated under 21 CFR 892.5900, within the Radiology medical specialty. This device is eligible for third-party review under FDA's accredited persons program.
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Basic Information
- Product Code
- IYH
- Device Class
- FDA class 2
- Regulation Number
- 892.5900
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K871116 | X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R | May 14, 1987 | Substantially Equivalent | X-Cel X-Ray Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.