K222655 is an FDA 510(k) clearance for the OtoSight Middle Ear Scope. This device is classified as a Device System, Imaging, Tympanic Membrane And Middle Ear (Class II - Special Controls, product code QJG).
Submitted by Photonicare, Inc. (Champaign, US). The FDA issued a Cleared decision on September 26, 2022, 24 days after receiving the submission on September 2, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 892.1560. Is Intended For Use As An Imaging Tool For Visualization Of The Human Tympanic Membrane And Middle Ear Space..
| 510(k) Number | K222655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2022 |
| Decision Date | September 26, 2022 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | QJG - Device System, Imaging, Tympanic Membrane And Middle Ear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |
| Definition | Is Intended For Use As An Imaging Tool For Visualization Of The Human Tympanic Membrane And Middle Ear Space. |