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LINEAR TOMOGRAPHIC SYSTEM: PMT 6000

K942175 Class II Traditional
Decision Date
1994-08-17
Sponsor / Applicant
Continental X-Ray Corp.

Technical Specification

510(k) Submission ID K942175
Product Code IZF
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1740
Decision Date 1994-08-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 received FDA 510(k) clearance under submission number K942175, sponsored by Continental X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-08-17.

Classification & Regulation

This clearance is catalogued under FDA product code IZF and 21 CFR 892.1740, within the Radiology review panel as a Class II device.