(65 days)
No
The description focuses on traditional signal processing techniques (amplitude-based color display, frame addition) and does not mention AI or ML.
No.
The device is described as a post-processing modification for an ultrasound system, designed to enhance the display of vascular structures and blood presence. It does not perform any direct therapeutic action or provide treatment.
No
The device is described as a post-processing modification to an existing display mode (Power Mode) that was cleared in K941352. Its function is to "accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow." This is a display enhancement for an imaging system, not a device that independently diagnoses a condition. Diagnostics typically involve analyzing data to identify a disease, condition, or pathological state. This device simply changes how an existing imaging modality's data is presented.
No
The device description explicitly states it is a "post-processing modification to the Power Mode display that was cleared with the SSA-340A system". The SSA-340A system is an ultrasonic imaging system, which is a hardware device. Color Angio is described as a feature of this hardware system, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro use: The description focuses on a post-processing modification for an ultrasonic imaging system used on a patient. There is no indication that this device is used to examine specimens (like blood, urine, or tissue) outside of the body.
- Focus on imaging and blood presence: The device is described as a display modification to accentuate vascular structures and signal the presence of blood within the body during an ultrasound examination.
- Predicate device is an imaging system: The predicate device (SSA-340A system) is an ultrasonic pulsed echo imaging system, which is used for in vivo imaging, not in vitro diagnostics.
IVD devices are specifically designed to be used in vitro to examine specimens from the human body to provide information for diagnostic purposes. This device clearly operates within the context of in vivo imaging.
N/A
Intended Use / Indications for Use
Not Found
Product codes
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Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.