FDA product code MJS: Contrast Media, Ultrasound
MJS is the FDA product code for contrast media, ultrasound. It is a Class III device, reviewed by the Radiology panel. Devices under MJS reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Contrast Media, Ultrasound |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MJS devices
openFDA lists no recalls for product code MJS.
Frequently asked questions
What is FDA product code MJS?
MJS is the FDA product code for contrast media, ultrasound. It is a Class III device, reviewed by the Radiology panel.
What device class is MJS?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MJS
- Run a recall and safety report across every MJS manufacturer
- Watch product code MJS 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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