Cleared Traditional

K812701 - ORTHO-THERM INFRARED SENSOR
(FDA 510(k) Clearance)

K812701 · Orthion Corp. · Radiology device

Oct 1981

Decision

20d

Days

Class 3

Risk

K812701 is an FDA 510(k) clearance for the ORTHO-THERM INFRARED SENSOR. This device is classified as a System, Telethermographic, Infrared (Class III - Premarket Approval, product code IYM).

Submitted by Orthion Corp. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981, 20 days after receiving the submission on September 23, 1981.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2980.

Submission Details

510(k) Number	K812701 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 23, 1981
Decision Date	October 13, 1981
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—