X-Cel X-Ray Models ORT90W, ORT90M and ORT90R
by X-Cel X-Ray Corp. 510(k)
Active
510(k) K871116
Overview
The X-CEL X-RAY Models ORT90W, ORT90M and ORT90R are x-ray radiation therapy systems designed to produce and control x-rays for therapeutic purposes. These devices are intended for use in medical settings, particularly in podiatry and orthopedics, where they provide adjustable kVp (peak kilovoltage) capabilities for various diagnostic and therapeutic applications.
The X-CEL X-RAY Models ORT90W, ORT90M and ORT90R are supplied as medical devices with FDA 510(k) clearance (K871116) and are classified under product code IYH. These devices are used in clinical environments for radiation therapy, with typical extremity exposures producing 25 to 30 mr. The models are designed for different applications within the 900 series, with specific configurations for various medical specialties.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871116 | Date14 May 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IYH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5900
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from X-Cel X-Ray Corp.
Questions
What are the X-CEL X-RAY Models ORT90W, ORT90M and ORT90R used for?
These are x-ray radiation therapy systems designed for medical settings, particularly in podiatry and orthopedics, where they produce and control x-rays for therapeutic purposes with adjustable kVp capabilities.
How are the X-CEL X-RAY Models ORT90W, ORT90M and ORT90R supplied?
The devices are supplied as medical equipment with FDA 510(k) clearance (K871116) and classified under product code IYH, designed for different applications within the 900 series for various medical specialties.
What radiation exposure levels do the X-CEL X-RAY Models produce?
These systems typically produce 25 to 30 milliroentgen (mr) for extremity exposures during clinical use in radiation therapy settings.
What distinguishes the ORT90W, ORT90M and ORT90R models from each other?
Each model is designed for specific applications within the 900 series, with different configurations tailored to various medical specialties, though the device data doesn't specify the exact differences between the models.