# Pilson Direct Trading Limited (foreign exporter, Newcastle Newcastle upon Tyne, GB): 11 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Pilson Direct Trading Limited |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Newcastle Newcastle upon Tyne, GB |
| New listings | 11 |
| Devices | System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic; Biopsy Needle Guide Kit |
| Product codes | IYN, IYO, ITX, OIJ |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System; ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER; ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System and accessories |
| First new listing | 2026-05-15 |
| Latest new listing | 2026-06-23 |
| FDA registration number | 3011763071 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.