FDA product code OQQ: Diagnostic Ultrasonic Transducer, Robotic
OQQ is the FDA product code for diagnostic ultrasonic transducer, robotic. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under OQQ. The average 510(k) review took 301 days (median 301).
Definition
Diagnostic ultrasonic imaging or monitoring.
Classification
| Field | Value |
|---|---|
| Device name | Diagnostic Ultrasonic Transducer, Robotic |
| Device class | Class II |
| Regulation | 21 CFR 892.1570 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OQQ clearance
Top OQQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shenzhen Delicate Electronics Co., Ltd. | 1 | 2010-05-13 |
Most recent OQQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092164 | Shenzhen Delicate Electronics Co., Ltd. | TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA | 2010-05-13 | 301 |
Recalls for OQQ devices
openFDA lists no recalls for product code OQQ.
Frequently asked questions
What is FDA product code OQQ?
OQQ is the FDA product code for diagnostic ultrasonic transducer, robotic. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the Radiology panel.
What device class is OQQ?
Class II, regulation 21 CFR 892.1570. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQQ?
Across 1 cleared submissions the average was 301 days from receipt to decision (median 301).
Which companies have the most OQQ clearances?
Shenzhen Delicate Electronics Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OQQ
- Run a recall and safety report across every OQQ manufacturer
- Watch product code OQQ 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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