Who is the manufacturer of HP SONOS ULTRASOUND IMAGING SYSTEM?

Hewlett-Packard Co. filed the 510(k) submission for HP SONOS ULTRASOUND IMAGING SYSTEM (K954028).

What is the FDA product code for HP SONOS ULTRASOUND IMAGING SYSTEM?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for HP SONOS ULTRASOUND IMAGING SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HP SONOS ULTRASOUND IMAGING SYSTEM?

ATL HDI 3000 (K935009); Toshiba SSA-380A (K933743).

Who can help prepare an FDA 510(k) submission like HP SONOS ULTRASOUND IMAGING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HP SONOS ULTRASOUND IMAGING SYSTEM

K954028 · Hewlett-Packard Co. · IYN · Aug 8, 1996 · Radiology

Device Facts

Record ID	K954028
Device Name	HP SONOS ULTRASOUND IMAGING SYSTEM
Applicant	Hewlett-Packard Co.
Product Code	IYN · Radiology
Decision Date	Aug 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2

Device Story

HP SONOS and Philips SonoDiagnost ultrasound imaging systems; modification involves transition from analog to digital circuit technology for front-end receive functions. Systems used for diagnostic ultrasound imaging across cardiovascular, obstetric, gynecologic, and neurological applications. Digital front-end processing improves signal handling; maintains clinical utility of existing ultrasound platforms. Operated by trained clinicians/sonographers in clinical settings. Output consists of diagnostic ultrasound images/data used for clinical decision-making. Benefits include enhanced performance and reliability associated with digital signal processing.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated through compliance with medical device safety standards (IEC 601, UL 2601), hazard analysis, and software validation.

Technological Characteristics

Digital circuit technology for front-end receive functions. Compliance with IEC 601 and UL 2601 safety standards. Software-based signal processing.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

ATL HDI 3000 (K935009)
Toshiba SSA-380A (K933743)

Related Devices

K073297 — GE LOGIQ P6 · General Electric Co. · Dec 18, 2007
K061083 — CTS-7700 · Shantou Institute of Ultrasonic Instuments · Jun 6, 2006
K070526 — DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 23, 2007
K070982 — CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM · Shantou Institute of Ultrasonic Instuments · May 2, 2007
K251651 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System · Philips Ultrasound, LLC · Oct 9, 2025

Submission Summary (Full Text)

{0} K954028 AUG 8 1996 # Attachment D: 510(k) SUMMARY of Safety and Effectiveness Submitted by: Rob Butler (contact person), Regulatory Approvals Medical Products Group Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810 phone (508) 659-2785; fax (508) 687-8284 Summary prepared August 25, 1995. **H2410A** Device Name: This modification applies to three devices (Device Trade Name HP M2406A, HP M2406R, and HP M2412A) in the HP SONOS Ultrasound Imaging System (Device Common Name) family, and to the SD000 in the Philips SonoDiagnost Ultrasound Imaging System family. Classification Name: FDA has classified Ultrasound Imaging Systems as Class II in 21 CFR: - 870.2100 Cardiovascular Blood Flowmeter - 870.2120 Extravascular Blood Flow Probe - 870.2330 Echocardiograph - 870.2880 Ultrasonic Transducer - 870.2890 Vessel Occlusion Transducer - 882.1240 Echoencephalograph - 884.2225 Obstetric-gynecologic Ultrasonic Imager - 884.2960 Obstetric Ultrasonic Transducer and Accessories - 892.1550 Ultrasonic Pulsed Doppler Imaging System - 892.1560 Ultrasonic Pulsed Echo Imaging System - 892.1570 Diagnostic Ultrasonic Transducer In this 510(k) submission, the legally marketed devices to which we claim equivalence are the ATL HDI 3000 (K935009) and the Toshiba SSA-380A (K933743) ultrasound imaging systems. Device Description: The modification addressed in this submission is a change from analog to digital circuit technology for the front end of the HP ultrasound imaging systems listed above. Intended Use: This modification has no effect on intended use of the HP ultrasound systems. Technological Characteristics: The modified HP ultrasound imaging systems will use the same type of digital circuit technology for front end receive functions as the predicate devices. The safety of this modification is shown by compliance to medical device safety standards (such as IEC 601 and UL 2601). Software safety is verified by hazard analysis and software validation to ensure performance specifications are met. This validation, safety testing, and comparison to legally marketed devices demonstrate that the modified HP ultrasound imaging systems are substantially equivalent to legally marketed predicate devices with regards to safety, effectiveness and intended use.