The following data is part of a De Novo classification by Infrascan, Inc. with the FDA for Infrascanner, Model 1000.
| DeNovo ID | DEN100002 |
| Device Name: | INFRASCANNER, MODEL 1000 |
| Classification | Infrared Hematoma Detector |
| Applicant | INFRASCAN, INC. 3508 Market St., Suite 215 Philadelphia, PA 19104 -3320 |
| Contact | Steven B Datlof |
| Product Code | OPT |
| CFR Regulation Number | 882.1935 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K080377 |
| Review Advisory Board | Neurology |
| Classification Advisory | Ophthalmic |
| Type | Post-NSE |
| Date Received | 2010-04-08 |
| Decision Date | 2011-12-13 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |