Identity
- Trade Name
- SonoSite Edge FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- P15000-68R FDA UDI
Identifiers
- Catalog Number
- P15000 FDA UDI
- Primary DI / UDI-DI
- 00841517105426 FDA UDI
- 510(k) Number
- K133454 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose ultrasound imaging system
SonoSite Edge by Fujifilm Sonosite, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose ultrasound imaging system.
- SE12-3 Gen II® — SUPERSONIC IMAGINE · Class II
- SUPERSONIC MACH 40 — SUPERSONIC IMAGINE · Class II
- HS50 — SAMSUNG MEDISON CO., LTD · Class II
- EBit Series Diagnostic Ultrasound System — CHISON Medical Technologies Co., Ltd. · Class II
- Display Module(M5, International, Alone) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- WS80A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- HS50 / HS60 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- MEDISONO — Medisono, LLC · Class II
Cleared under the same submission
K133454 also covers:
- Battery — Fujifilm Sonosite, Inc.
- Edge Mini-Dock — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (1)
- FDA UDI d5e5ef4e-7ba1-4012-8244-358b27161058 35 fields · synced May 30, 2026