FDA product code LQA: Media, Reusable Image
LQA is the FDA product code for media, reusable image. It is a Class I device, regulated under 21 CFR 892.1840 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under LQA. The average 510(k) review took 129 days (median 129).
Classification
| Field | Value |
|---|---|
| Device name | Media, Reusable Image |
| Device class | Class I |
| Regulation | 21 CFR 892.1840 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Top LQA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Digirad Corp. | 1 | 1986-03-10 |
Most recent LQA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854407 | Digirad Corp. | DIGIRAD REUSABLE IMAGE MEDIA | 1986-03-10 | 129 |
Recalls for LQA devices
openFDA lists no recalls for product code LQA.
Frequently asked questions
What is FDA product code LQA?
LQA is the FDA product code for media, reusable image. It is a Class I device, regulated under 21 CFR 892.1840 and reviewed by the Radiology panel.
What device class is LQA?
Class I, regulation 21 CFR 892.1840. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LQA?
Across 1 cleared submissions the average was 129 days from receipt to decision (median 129).
Which companies have the most LQA clearances?
Digirad Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LQA
- Run a recall and safety report across every LQA manufacturer
- Watch product code LQA 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.