← Product Code [ITY](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY) · K913987

# OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID (K913987)

_Codman & Shurtleff, Inc. · ITY · Apr 13, 1992 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K913987

## Device Facts

- **Applicant:** Codman & Shurtleff, Inc.
- **Product Code:** [ITY](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY.md)
- **Decision Date:** Apr 13, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1760
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K913987](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K913987)

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