K828545Substantially Equivalent

Maxicamera 500A Small Field Imaging System

Name: K828545 Maxicamera 500A Small Field Imaging System
Creator: General Electric Co.
Published: 1982-12-20
License: https://open.fda.gov/license/

General Electric Co., Schenectady NY / Traditional, Substantially Equivalent

FDA source

K828545 is the FDA 510(k) clearance record for MAXICAMERA 500A SMALL FIELD IMAGING SYSTEM, cleared for General Electric Co. on 1982-12-20. FDA records list 256 510(k) clearances for General Electric Co., from 1976-08-26 to 2011-12-22. As of 2026-09-10, FDA records show no recalls naming K828545.

Clearance record

Decision date: 1982-12-20
Received: 1982-11-18 (32 days to decision)
Review panel: Unknown
Applicant: General Electric Co. 1 River Rd., Schenectady NY
Third party review: No