← Product Code [JWM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM) · K901545

# GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM (K901545)

_Toshiba America Medical Systems, In.C · JWM · Jun 26, 1990 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K901545

## Device Facts

- **Applicant:** Toshiba America Medical Systems, In.C
- **Product Code:** [JWM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM.md)
- **Decision Date:** Jun 26, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1310
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K901545](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K901545)

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