Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.
K800491 is an FDA 510(k) clearance for the GRAPHIC STRESS TELETHERMOMETRY. Classified as System, Telethermographic, Infrared (product code IYM), Class III - Premarket Approval.
Submitted by Gst Laboratories of Ca, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1980.
This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.
| 510(k) Number | K800491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | March 04, 1980 |
| Decision Date | March 04, 1980 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | IYM System, Telethermographic, Infrared |
| Device Class | Class 3 - Premarket Approval |
| CFR Regulation | 21 CFR 884.2980 |
Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.