FDA product code SHL: Ear, Nose, And Throat Image Analyzer
SHL is the FDA product code for ear, nose, and throat image analyzer. It is a Class II device, regulated under 21 CFR 874.4775 and reviewed by the Ear, Nose and Throat panel. Devices under SHL reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions.
Classification
| Field | Value |
|---|---|
| Device name | Ear, Nose, And Throat Image Analyzer |
| Device class | Class II |
| Regulation | 21 CFR 874.4775 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Recalls for SHL devices
openFDA lists no recalls for product code SHL.
Frequently asked questions
What is FDA product code SHL?
SHL is the FDA product code for ear, nose, and throat image analyzer. It is a Class II device, regulated under 21 CFR 874.4775 and reviewed by the Ear, Nose and Throat panel.
What device class is SHL?
Class II, regulation 21 CFR 874.4775. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SHL
- Run a recall and safety report across every SHL manufacturer
- Watch product code SHL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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