← Product Code [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK) · K011160

# E-Z EM PERCUPUMP 2001 CT INJECTOR (K011160)

_E-Z-Em, Inc. · JAK · May 16, 2001 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K011160

## Device Facts

- **Applicant:** E-Z-Em, Inc.
- **Product Code:** [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK.md)
- **Decision Date:** May 16, 2001
- **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/JAK/K011160](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K011160)

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