Product code IYI— Radiology
37-702 AND 37-703 PC RAINBOW
- Classification name
- Collimator, Orthovoltage, Therapeutic X-Ray
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code IYI
FDA has cleared devices under product code IYI between 1990 and 1992, filed by 2 applicant companies. 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.
Clearances per year
- 1992
- 1990
Top applicants under product code IYI
Recent clearances under product code IYI
Data sourced from openFDA. This site is unofficial and independent of the FDA.