FDA product code QTO: Digital Visual Acuity Test
QTO is the FDA product code for digital visual acuity test. It is a Class I device, regulated under 21 CFR 886.1150 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under QTO, 1 in the last five years. The average 510(k) review took 213 days (median 213).
Definition
A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients.
Classification
| Field | Value |
|---|---|
| Device name | Digital Visual Acuity Test |
| Device class | Class I |
| Regulation | 21 CFR 886.1150 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QTO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 213 |
Compare with all 510(k) review times · Search every QTO clearance
Top QTO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Visibly, Inc. | 1 | 2022-08-12 |
Most recent QTO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220090 | Visibly, Inc. | Visibly Digital Acuity Product | 2022-08-12 | 213 |
Recalls for QTO devices
openFDA lists no recalls for product code QTO.
Frequently asked questions
What is FDA product code QTO?
QTO is the FDA product code for digital visual acuity test. It is a Class I device, regulated under 21 CFR 886.1150 and reviewed by the Ophthalmic panel.
What device class is QTO?
Class I, regulation 21 CFR 886.1150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QTO?
Across 1 cleared submissions the average was 213 days from receipt to decision (median 213).
Which companies have the most QTO clearances?
Visibly, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QTO
- Run a recall and safety report across every QTO manufacturer
- Watch product code QTO 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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