Cleared Traditional

K870821 - POLYTRON MODELS 1001, 1002 AND 1004 (FDA 510(k) Clearance)

K870821 · Siemens Medical Solutions USA, Inc. · Radiology device

Jul 1987

Decision

120d

Days

Class 2

Risk

K870821 is an FDA 510(k) clearance for the POLYTRON MODELS 1001, 1002 AND 1004. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on July 1, 1987, 120 days after receiving the submission on March 3, 1987.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K870821 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 03, 1987
Decision Date	July 01, 1987
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—