# Philips Ultrasound LLC (contract manufacturer, Reedsville, PA): 32 new FDA device listings, incl. computer-assisted diagnostic software for lesions suspicious for cance

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Philips Ultrasound LLC |
| Owner / operator | Philips Medical Systems International BV |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Reedsville, PA, US |
| New listings | 32 |
| Devices | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer; Automated Radiological Image Processing Software; Catheter, Ultrasound, Intravascular; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Image Processing, Radiological |
| Product codes | POK, QIH, OBJ, ITX, IYO, IYN, LLZ |
| Device classes | Class II |
| Medical specialties | Radiology, Cardiovascular |
| Brand names | Affiniti Series Diagnostic Ultrasound System; Epiq Series Diagnostic Ultrasound System; Koios DS; EPIQ Inspira Series Diagnostic Ultrasound System; mL26-8; X5-1; V9-2; X8-2t |
| First new listing | 2026-06-09 |
| Latest new listing | 2026-09-30 |
| FDA registration number | 2518586 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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: 2026-11-04T21:52:36.524Z.
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.