(77 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 description states it is a "post-processing modification to the Power Mode display" for imaging ("color doppler imaging") and "accents minute vascular structures and signals the presence of blood". These functions are related to diagnosis and image processing, not therapy.
No
The device description indicates it is a "post-processing modification to the Power Mode display" for visualizing "minute vascular structures and signal the presence of blood". It is a display feature for imaging, not a device that directly diagnoses a medical condition or disease.
No
The device description explicitly states it is a "post-processing modification to the Power Mode display that was cleared with the SSA-380A system". This indicates it is a software feature integrated into or modifying an existing hardware system (the SSA-380A system), not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that "Color Angio is a post-processing modification to the Power Mode display" of an ultrasound system. It's a feature that modifies the display of imaging data acquired from within the body.
- Input Modality: The input is "Color doppler imaging," which is an in-vivo imaging technique, not an in-vitro test.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting substances in samples, or any other activity typically associated with IVDs.
Therefore, Color Angio is a feature of an imaging system used for in-vivo diagnosis, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
90-IYN
Device Description
Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-380A system in K933743. 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
Mentions image processing
Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-380A system in K933743.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
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
DEC - 3 1996
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: | Color Enhancement Function for the SSA-380A |
| Common Name: | Amplitude Doppler |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging System Accessory |
| [Fed. Reg. No.: 892.1550, Pro. Code: 90-IYN] | |
| Device Track: | Track 3 |
| Regulatory Class: | II |
| Image: [signature] | |
| 514 Performance Standards: | None |
| Special Controls: | None |
| Prescription Status: | Prescription Device |
Reason for Submission:
Modification of the SSA-380A
Substantial Equivalence Summary:
Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-380A system in K933743. 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 ្រី ប្រទេស ស្រុក កំពង់ អាក់ ការ ការ ការ ប្រទេស ប្រទេស ក្រុង ប្រទេស ក្រុង ប្រទេស ក្រុង ប្រទេស ក្រុង ប្រទេស ក្រុង ប្រ