← Product Code [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK) · K881305

# TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM (K881305)

_Toshiba Medical Systems · JAK · Oct 19, 1988 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K881305

## Device Facts

- **Applicant:** Toshiba Medical Systems
- **Product Code:** [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK.md)
- **Decision Date:** Oct 19, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **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/JAK/K881305](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K881305)

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