K970047 · Toshiba America Medical Systems, In.C · ITX · Mar 4, 1997 · Radiology
Device Facts
Record ID
K970047
Device Name
PHASED ARRAY TRANSDUCER - - PSK-20CT
Applicant
Toshiba America Medical Systems, In.C
Product Code
ITX · Radiology
Decision Date
Mar 4, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1570
Device Class
Class 2
Indications for Use
The PSK-20CT phased array transducer is intended for use with the SSA-380A diagnostic ultrasound system for adult transcranial imaging.
Device Story
Phased array transducer (PSK-20CT) designed for use with SSA-380A diagnostic ultrasound system; enables adult transcranial imaging. Device functions as acoustic probe; transmits/receives ultrasound signals for image reconstruction by host system. Operated by clinicians in clinical settings. Output displayed on system monitor for diagnostic interpretation. Benefits include non-invasive visualization of intracranial structures.
Clinical Evidence
No clinical data provided. Substantial equivalence based on technological similarity and software verification/validation procedures.
Technological Characteristics
Phased array ultrasound transducer. Acoustic output intensities and patient contact materials unchanged from cleared predicates. Connectivity via proprietary interface to SSA-380A system.
Indications for Use
Indicated for adult transcranial diagnostic ultrasound imaging.
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.
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K970047
MAR - 4 1997
# 510(k) Summary
Submitter’s Name: Toshiba America Medical Systems, Inc.
Submitter’s Address: P.O. Box 2068, 2441 Michelle Drive, Tustin CA 92781-2068
Submitter’s Contact: Steven M. Kay, Regulatory Affairs Specialist, (714) 730-5000
Establishment Registration Number: 2020563
Device Proprietary Name: Phased Array Transducer - - PSK-20CT
Common Name: Diagnostic Ultrasound Transducer
[Fed. Reg. No.: 892.1570, Pro. Code: 90-ITX]
Regulatory Class: II
514 Performance Standards: None
Special Controls: None
Prescription Status: Prescription Device
## Reason for Submission:
Modification of the SSA-380A
## Substantial Equivalence Summary:
The PSK-20CT phased array transducer will add adult transcranial indications for use to the SSA-380A diagnostic ultrasound system. The addition of the PSK-20CT transducer follows the same software verification and validation procedures and employs the same general technology as that previously cleared for the SSA-380A system and transducers in K933743. The SSA-380A system software and hardware is only upgraded to recognize the addition of the PSK-20CT. Cleared patient contact materials and acoustic output intensities are unchanged. No other system changes were required. The PSK-20CT transducer is similar to the PSH-25GT transducer that was cleared for transcranial use with the SSA-270A and SSH-140A diagnostic ultrasound systems in K941593.
Based on a review of TAMS Complaint and MDR files for similar transducers, any potential failure of this transducer is not expected to result in an injury to the patient.
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