← Product Code [OAS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS) · K260462

# RCT800 (K260462)

_Ray Co., Ltd. · OAS · Apr 9, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS/K260462

## Device Facts

- **Applicant:** Ray Co., Ltd.
- **Product Code:** [OAS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS.md)
- **Decision Date:** Apr 9, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 892.1750
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS/K260462](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS/K260462)

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