DVS Option 01
by O.M.I. Oncology Microsystems, Inc. 510(k)
Active
510(k) K883101
Overview
The DVS Option 01 is a Linear Medical Accelerator, a Class II device used in radiation therapy to deliver high-energy electron and photon beams for cancer treatment. It operates by accelerating electrons to high velocities, converting them into X-ray photons or directing them as electron beams for precise tumor irradiation. The device is designed for clinical use in radiotherapy departments, where controlled radiation doses are essential for therapeutic outcomes.
This device is supplied as a reusable medical instrument, intended for use in MRI-unsafe environments due to its electromagnetic properties. It is regulated under FDA 510(k) clearance (K883101) and falls under the Radiology specialty category, with a regulatory classification of IYE. Sterilization and maintenance protocols must adhere to clinical radiation safety standards, and its operation requires trained personnel in compliance with radiation protection guidelines. The device is not single-use and must be serviced according to manufacturer specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883101 | Date7 Oct 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from O.M.I. Oncology Microsystems, Inc.
Questions
What is the DVS Option 01 used for?
The DVS Option 01 is a Linear Medical Accelerator designed specifically for radiation therapy in oncology. It generates high-energy electron and photon beams to target and treat tumors with controlled doses, ensuring precise and effective cancer treatment outcomes.
Is the DVS Option 01 a single-use or reusable device?
The DVS Option 01 is a reusable medical instrument. It is not intended for single-use and must be maintained and serviced according to the manufacturer’s specifications to ensure proper functionality and safety in clinical settings.
Where can the DVS Option 01 be used, and what safety considerations apply?
This device is intended for use in radiotherapy departments and must be operated in MRI-unsafe environments due to its electromagnetic properties. Strict adherence to clinical radiation safety standards, sterilization protocols, and regular maintenance is required to ensure safe operation.
What regulatory approval does the DVS Option 01 hold?
The DVS Option 01 holds FDA 510(k) clearance under the classification of IYE, with the clearance number K883101. It is categorized under the Radiology specialty and is regulated under the FDA’s traditional 510(k) pathway.
Who should operate the DVS Option 01, and what training is required?
The DVS Option 01 must be operated by trained personnel who comply with radiation protection guidelines. Proper training ensures safe handling, accurate beam delivery, and adherence to clinical protocols for effective cancer treatment.