# Philips Ultrasound LLC (manufacturer, Bothell, WA): 36 new FDA device listings, incl. catheter, ultrasound, intravascular

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Philips Ultrasound LLC |
| Owner / operator | Philips Medical Systems International BV |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Bothell, WA, US |
| New listings | 36 |
| Devices | Catheter, Ultrasound, Intravascular; System, Image Processing, Radiological; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic; Automated Radiological Image Processing Software; System, Imaging, Pulsed Doppler, Ultrasonic; Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Product codes | OBJ, LLZ, IYO, ITX, QIH, IYN, POK |
| Device classes | Class II |
| Medical specialties | Cardiovascular, Radiology |
| Brand names | Affiniti Series Diagnostic Ultrasound System; EPIQ Inspira Series Diagnostic Ultrasound System; C10-3v; D5cwc; mC7-2; Alturion Series Diagnostic Ultrasound System; S5-1; mL26-8 |
| First new listing | 2026-06-09 |
| Latest new listing | 2026-09-30 |
| FDA registration number | 3019216 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

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: 2026-10-28T20:51:27.468Z.
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.