# Butterfly Network, Inc. (specification developer, Burlington, MA): 4 new FDA device listings, incl. transducer, ultrasonic, diagnostic

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Butterfly Network, Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Burlington, MA, US |
| New listings | 4 |
| Devices | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Automated Radiological Image Processing Software |
| Product codes | ITX, IYN, IYO, QIH |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | Butterfly Gestational Age Tool |
| First new listing | 2026-09-11 |
| Latest new listing | 2026-09-11 |
| FDA registration number | 3010102386 |
| 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.

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.