SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM

K970034 · Hewlett-Packard Co. · ITX · Mar 17, 1997 · Radiology

Device Facts

Record IDK970034
Device NameSD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
ApplicantHewlett-Packard Co.
Product CodeITX · Radiology
Decision DateMar 17, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1570
Device ClassClass 2

Device Story

SD 800 SonoDiagnost Ultrasound Imaging System; diagnostic ultrasound imaging. Modification involves new patient contact materials for EV transducer. System utilizes existing transducer technology; acoustic performance maintained. Used in clinical settings for ultrasound imaging; provides diagnostic information to clinicians. Benefits include continued diagnostic capability with updated material components.

Clinical Evidence

Bench testing only; acoustic performance evaluated per Appendix I of the February 1993 Ultrasound Guidance.

Technological Characteristics

Ultrasound imaging system; EV transducer with updated patient contact materials. Acoustic performance consistent with predicate. No software or algorithm details provided.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} MAR 17 1997 Attachment C SD 800 SW Modification K970034 510(k) Summary of Safety and Effectiveness: 21 CFR 807.92 1) Submitter's Name / Contact Person: Paul Schrader Address: 3000 Minuteman Road, Andover Ma. 01810 Telephone Number: 508-659-2404 Date Summary was prepared: December 16, 1996 2) Trade Name: SD 800 SonoDiagnost Ultrasound Imaging System Common Name: Ultrasound Imaging System Classification Pro Codes: 90 IYN & 90 IYQ 3) Identification of Predicate Device: The predicate device for this submittal is the existing SD 800 and EV transducer which were reviewed by FDA on the SD 800 system that was submitted as part of K935923. 4) Description of the device or modification being submitted for premarket approval. Functionality: The new EV transducer has equivalent functionality to the existing transducer now being used. Scientific Concepts: same as existing EV transducer Significant Characteristics of the Modification: The new EV transducer has new patient contact materials. It is this change that creates the need to file a 510(k) with the FDA. The transducer is an existing transducer being sold and marketed by Echo ultrasound. Acoustic performance of the system / transducer combination will be handled as a 510(k) to file based on Appendix I of the February 1993 Ultrasound Guidance. 5) Statement of Intended Use: No change from existing SD 800 platform reviewed during 510(k) 935923. 6) Predicate Device Comparison: There are no significant differences in safety and efficacy between the 21370A and 21370B transducers. A detailed comparison of the transducers can be found in the 510(k) report.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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