Product code IYH— Radiology
X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R
- Classification name
- Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code IYH
FDA has cleared device under product code IYH, all in 1987, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code IYH
Recent clearances under product code IYH
Data sourced from openFDA. This site is unofficial and independent of the FDA.