← Product Code [IYW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYW) · K882453

# POLYSCAN DIGITAL SCANNER (K882453)

_Medical and Scientific Enterprises, Inc. · IYW · Nov 23, 1988 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYW/K882453

## Device Facts

- **Applicant:** Medical and Scientific Enterprises, Inc.
- **Product Code:** [IYW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYW.md)
- **Decision Date:** Nov 23, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1300
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient. This generic type of device 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/IYW/K882453](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYW/K882453)

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