HP Sonos 100CF Ultrasound Imaging System
by Hewlett-Packard Co. 510(k)
Active
510(k) K955327
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955327 | Date8 Apr 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The HP Sonos 100CF Ultrasound Imaging System is a diagnostic ultrasound imaging system. It is designed to perform ultrasound imaging for various clinical applications, including obstetrics and gynecology.
This device has received FDA 510(k) clearance under K955327 and K922184. It is manufactured by Hewlett-Packard Co. and is categorized as a Class II medical device.
Other devices from Hewlett-Packard Co.
Questions
AI-generated answers, 21 Sep 2026
What is the primary clinical use of the HP Sonos 100CF?
The HP Sonos 100CF is a diagnostic ultrasound imaging system intended for use in various clinical applications, with specific capabilities for obstetrics and gynecology imaging.
What is the regulatory status of this imaging system?
The HP Sonos 100CF is a Class II medical device that has received FDA 510(k) clearance, as documented under submission numbers K955327 and K922184.
Who is the manufacturer of the Sonos 100CF?
This ultrasound imaging system is manufactured by Hewlett-Packard Co., located in Andover, Massachusetts.