OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID
Device Facts
| Record ID | K913987 |
|---|---|
| Device Name | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID |
| Applicant | Codman & Shurtleff, Inc. |
| Product Code | ITY · Radiology |
| Decision Date | Apr 13, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1760 |
| Device Class | Class 1 |
Regulatory Classification
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.
