The following data is part of a premarket notification filed by Image Systems, Inc. with the FDA for Infraview/infrasion-telethermographic System.
| Device ID | K844771 |
| 510k Number | K844771 |
| Device Name: | INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | IMAGE SYSTEMS, INC. 430 10TH.ST.N.W.STE.N-209 Atlanta, GA 30318 |
| Contact | Richard P Hartwig |
| Correspondent | Richard P Hartwig IMAGE SYSTEMS, INC. 430 10TH.ST.N.W.STE.N-209 Atlanta, GA 30318 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-07 |
| Decision Date | 1985-02-27 |