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RADIATION THERAPY TREAT. PLAN. SYS.

K780278 Class II Traditional
Decision Date
1978-03-02
Sponsor / Applicant
Pfizer Medical Systems, Inc.

Technical Specification

510(k) Submission ID K780278
Product Code JAD
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.5900
Decision Date 1978-03-02
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

RADIATION THERAPY TREAT. PLAN. SYS. received FDA 510(k) clearance under submission number K780278, sponsored by Pfizer Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1978-03-02.

Classification & Regulation

This clearance is catalogued under FDA product code JAD and 21 CFR 892.5900, within the Radiology review panel as a Class II device.