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Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-340A system in K941352. It is an amplitude based color display subset of color doppler imaging that performs frame addition to accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow. This feature is independent of velocity, angle of incidence and direction of interrogation and reduces the effects of aliasing. It does not change the acoustic output or doppler sensitivity characteristics of the SSA-340A system.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the device's classification, compliance with performance standards, and a summary of its substantial equivalence to a previously cleared device.
Therefore, I cannot provide the requested table and information based on the provided text.
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2460602
510(k) Summary
| Date: | 26 February 1996 |
|---|---|
| Submitter: | Toshiba America Medical Systems, Inc. |
| 2441 Michelle Drive | |
| P.O. Box 2068 | |
| Tustin, CA 92681-2068 | |
| Contact: | Steven M. Kay |
| (714) 730-5000 | |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System Modification |
| Classification: | Class II per 21 CFR 892.1560 |
| Device Tier: | 2, according to the December 15, 1993 DRAERD Triage Pilot Program |
| Common Name: | Amplitude Doppler |
| Proprietary Name: | Color Angio |
| Model Name: | Color Angio for the SSA-340A Diagnostic Ultrasound System |
| Establishment Registration Number: | 2020563 |
Compliance With Performance Standards:
MAR 2 1 1996
This device complies with the Performance Standards for Electronic Products, 21 CFR 1010, as administered by the Center for Devices and Radiological Health and with CDRH guidances "Revised 510(k) Diagnostic Ultrasound Guidance for 1993", "510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices"and "Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment". It also complies with the Japanese (IIS) and European (IEC-601-1) voluntary standards and the ISO-9001 manufacturing standard.
Substantial Equivalence Summary:
Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-340A system in K941352. It is an amplitude based color display subset of color doppler imaging that performs frame addition to accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow. This feature is independent of velocity, angle of incidence and direction of interrogation and reduces the effects of aliasing. It does not change the acoustic output or doppler sensitivity characteristics of the SSA-340A system.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.