# K090158: Aplio Artida V2.0 SSH-880CV

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Feb 6, 2009 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894632 (1989). 60 ancestors in all.
98 later devices descend from it; 2 cite it directly.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080160: Aplio Artida, Model SSH-880CV Diagnostic Ultrasound System, Toshiba America Medical Systems, In.C (2008) Summary page 1.
- K082119: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0, Toshiba America Medical Systems, In.C (2008) Summary page 1.

## Most influential descendants
- K110870: Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System (2011), 89 descendants of its own
- K121422: Aplio 500/400/300 Diagnostic Ultrasound System (2012), 85 descendants of its own
- K123992: Aplio 500/400/300 V3.0 (2013), 82 descendants of its own
- K133761: Aplio 500/400/300 Diagnostic Ultrasound System V4.0 (2014), 72 descendants of its own
- K142517: SoftVue (2014), 49 descendants of its own

## Recalls of this device
- Oct 1, 2010 · Not classified · Z-2897-2011: Toshiba America Medical Systems, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., syst
- Sep 28, 2010 · Not classified · Z-1498-2011: Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues.
- Apr 20, 2010 · Not classified · Z-2179-2011: There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely.
- Jan 6, 2010 · Not classified · Z-2203-2011: Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values.
- Sep 16, 2009 · Not classified · Z-1955-2010: Toshiba America Medical Systems (TAMS) is initiating a field correction on the SSH-880CV Aplio Artida System due to a problem related to a wrong measurement value display in using with DICOM viewer. W

## Indications for use
This device is intended to be used for the following type of studies; cardiac, transesophageal, abdominal and peripheral vascular.

Source page: https://510kreport.com/device/K090158
Methodology: https://510kreport.com/methodology