Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The document explicitly mentions "Activation Imaging (AI)" as a new feature, describes its function in analyzing myocardial movement from 3D images, and details a clinical evaluation conducted for its validation. While the term "AI" is used, the description aligns with image processing and analysis techniques often associated with AI/ML in medical imaging.

Therapeutic

No.
The intended use of the device is to visualize structures for diagnosis, which is a diagnostic purpose, not therapeutic.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states that the system provides "image information for diagnosis" and is a "DIAGNOSTIC ULTRASOUND SYSTEM". The 'Device Description' also refers to it as a "mobile Ultrasound Diagnostic System".

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a main console, a color LCD display, and several transducers, which are hardware components. While it has various software options, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the system is used to "visualize structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis". This describes an in vivo diagnostic imaging device, not an in vitro diagnostic device.
Device Description: The description details a "mobile Ultrasound Diagnostic System" that uses transducers to acquire images of the human body. This is consistent with an in vivo imaging system.
Anatomical Site: The listed anatomical sites (cardiac, vascular, abdominal, etc.) are all within the human body, which is the target of in vivo imaging.
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body. This device does not perform such tests.

While the device uses advanced software features like "Activation Imaging (AI)" for analyzing the acquired ultrasound images, the fundamental function is to acquire images from within the body for diagnostic purposes. This firmly places it in the category of an in vivo diagnostic imaging device.

PCCP (Predetermined Change Control Plan) Authorized

No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The "Control Plan Authorized (PCCP) and relevant text" section explicitly states "Not Found".

Overview

Intended Use / Indications for Use

The intended use of this system is to visualize structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis for cardiac and vascular.
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical applications vary by transducer.

Product codes

90-IYN, 90-IYO, 90-ITX

Device Description

The APLIO ARTIDA SSH-880CV is a mobile Ultrasound Diagnostic System for cardiology and vascular imaging. It has a capability of providing a 3D real time image of a heart as well as 2D images. The system is consists of a main console, a color LCD display and several transducers. The compatible transducers are linear array, curved linear and phased array with a frequency range of 2.5 MHz to 7.5MHz. Accordingly it has various software options for cardiac and vascular examinations.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Activation Imaging (AI) - 3D Wall Motion Tracking (3D WMT), cleared by K090158, is a software to analyze the movement of the myocardium from the acquired 3D images. The Activation Imaging (AI) is added as a new feature of the 3D WMT. This is one of the strain display mode with a color coding depending on the arrival time to the defined strain value. And the color remains over after the arrival of the defined strain value. The addition of Activation Imaging feature to the 3D Wall Motion Tracking will allow the display of wall motion information of the myocardium with the use of color coding.

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac, vascular, abdominal, small organ, musculoskeletal, trans-esophageal. Specific anatomical sites vary by transducer.

Indicated Patient Age Range

Adult male and female, ages 18 and above, scheduled for routine Echocardiographic Evaluation by their physician and with dyssynchrony. Pediatric for Cardiac studies.

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

Clinical Test: A clinical evaluation of Activation Imaging (AI) was conducted at a evaluation site for the validation of AI.
Subjects: Adult male and female, ages 18 and above, scheduled for routine Echocardiographic Evaluation by their physician and with dyssynchrony.
Study endpoints: The primary endpoint was the collection of images from 10 subjects. A pass/fail criterion was used to determine if the AI images provided the activation timing.
Adverse Events: There were no adverse events during the course for the clinical evaluation.
Results: The result of the clinical evaluation satisfied a pass criterion.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Tests: Testing was conducted utilizing phantoms and accepted image quality metrics.
Clinical Test: A clinical evaluation of Activation Imaging (AI) was conducted at a evaluation site for the validation of AI. Subjects: Adult male and female, ages 18 and above, scheduled for routine Echocardiographic Evaluation by their physician and with dyssynchrony. Study endpoints: The primary endpoint was the collection of images from 10 subjects. A pass/fail criterion was used to determine if the AI images provided the activation timing. Adverse Events: There were no adverse events during the course for the clinical evaluation. Results: The result of the clinical evaluation satisfied a pass criterion.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Toshiba APLIO ARTIDA MODEL SSH-880CV Ultrasound Diagnostic System, K090158

Reference Device(s)

K090158, K103629

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

JUN 2 2 2012

510(k) - SUMMARY OF SAFETY AND EFFECTIVNESS

In accordance with 21 CFR 807.92, the following summary of the information is provided.

Submitter's Name: Toshiba America Medical Systems, Inc.

1. Address: 2441 Michelle Drive Tustin, CA 92780-2068

3. Establishment Registration: 2020563

4. Contact Person:

Charlemagne Chua

Manager Regulatory Affairs

(714) 730-5000

1. Submission Date May 30, 2012 (revised June 20, 2012)

6. Device Proprietary Name: APLIO ARTIDA MODEL SSH-880CV V3.0

1. Common Name:
  Diagnostic Ultrasound System

8. Classification:

Regulatory Class: II

Review Category: Tier II

Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [CFR 892.1550] Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [CFR 892.1560]

Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [CFR 892.1570]

9. Predicate Devices:

Toshiba APLIO ARTIDA MODEL SSH-880CV Ultrasound Diagnostic System, K090158

10. Device Description:

The APLIO ARTIDA SSH-880CV is a mobile Ultrasound Diagnostic System for cardiology and vascular imaging. It has a capability of providing a 3D real time image of a heart as well as 2D images. The system is consists of a main console, a color LCD display and several transducers. The compatible transducers are linear array, curved linear and phased array with a frequency range of 2.5 MHz to 7.5MHz. Accordingly it has various software options for cardiac and vascular examinations.

1

11. Summary of Intended Uses:

The intended use of this system is to visualize structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis for cardiac and vascular.

12. Technological characteristics:

The APLIO ARTIDA SSH-880CV V3.0 (subject device) employs the same scientific technology as the APLIO ARTIDA SSH-880CV V2.0 (predicate device).

13. New Feature .

Activation Imaging (AI) - 3D Wall Motion Tracking (3D WMT), cleared by K090158, is a software to analyze the movement of the myocardium from the acquired 3D images. The Activation Imaging (AI) is added as a new feature of the 3D WMT. This is one of the strain display mode with a color coding depending on the arrival time to the defined strain value. And the color remains over after the arrival of the defined strain value.

14. Determination of Substantial Equivalence:

Toshiba Medical Systems Corporation believes that the APLIO ARTIDA SSH-880CV V3.0 is substantially equivalent to APLIO ARTIDA SSH-880CV V2.0.

15. Safety:

This device is designed and manufactured under the Quality System Regulations as outlined under 21 CFR8820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37 and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.

16. Summary of Testing

a. Bench Tests

Testing was conducted utilizing phantoms and accepted image quality metrics.

b. Clinical Test

A clinical evaluation of Activation Imaging (AI) was conducted at a evaluation site for the validation of AI.

i. Subjects - Adult male and female, ages 18 and above, scheduled for routine Echocardiographic Evaluation by their physician and with dyssynchrony.
Study endpoints The primary endpoint was the collection of images from 10 ii. subjects. A pass/fail criterion was used to determine if the AI images provided the activation timing.
iii. Adverse Events - There were no adverse events during the course for the clinical evaluation.
Results The result of the clinical evaluation satisfied a pass criterion. iv.

2

ﻥ ﺑ Discussion

The predicate device is Aplio Artida SSH-880CV V2.0. The changes from V2.0 to this device are the addition of 6 transducers (PVT-375BT, PET-510MB, PST-25BT, PLT-704AT, PET-508MA and PET-512MC) and the addition of the Activation Imaging (AI) to the wall motion tracking. The addition of the transducers does not change the intended use range of this device. The addition of Activation Imaging feature to the 3D Wall Motion Tracking will allow the display of wall motion information of the myocardium with the use of color coding. This does not change the effectiveness and the safety of the device.

17. Conclusion:

New feature that is being added to the Aplio Artida SSH-880CV V3.0 do not change the indication for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to this modification.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

JUN 22 2012

Toshiba Medical Systems Corporation, Japan % Ms. Charlemagne Chua Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K121577

Trade/Device Name: Aplio ArtidaTM (SSH-880CV), v3.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 29, 2012 Received: May 30, 2012

Dear Ms. Chua:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Aplio Artida™ (SSH-880CV), v3.0, as described in your premarket notification:

Transducer Model Number
PST-25SX	PST-25BT
PST-30BT	PVT-375BT
PTS-30SBT	PLT-704AT
PST-50BT	PET-508MA
PST-65AT	PET-510MB
PLT-704SBT	PET-512MC
PC-20M

4

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.

Sincerely Yours.

Michael D'Okon for

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

5

Indications for Use

510(k) Number (if known):

Device Name:

Aplio Artida™ (SSH-880CV), v3.0

Indications for Use:

The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.

Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number Kla1577

6

510(k) Premarket Notification .

Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

SSH-880CV System: __ Transducer: __________________________________________________________________________________________________________________________________________________________________

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | P | P | P | P | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | P | P | P | | P | P | P | P | P | | | |
| Musculo-skeletal (Superficial) | P | P | P | | P | P | P | P | P | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac Pediatric | P | P | P | P | P | P | P | P | P | P | P | P |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | | | P | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | P | P | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510k of the transducer:K090158

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K.

7

510(k) Premarket Notification Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

System:	SSH-880CV
Transducer:	PST-25SX

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | | | | | | P | | | | | P |
| Cardiac Pediatric | P | | | | | | P | | | | | P |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer:K090158

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

(Division Sign-Off)

Division of Radic logical Liamces Office of In Vitro Diagnostic Device Evaluation and Safety

510K

8

510(k) Premarket Notification

Aplio Artida TM(v3.0) SSH-880CV Ultrasound System

System:	SSH-880CV
Transducer:	PST-30BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	જિ	M	PWD CWD	Color
Doppler	Combined
(Specify)

| | THI Dynamic
Flow | Power | .I.DI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | b | b | P | P | P | P | P | P | b | |
| Cardiac Pediatric | P | P | P | P | P | P | P | P | P | P | P | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer:K090158

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Michael D. O'Brien
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety ﮯ 510K

510(K): Aplio Artida v3.0 (SSH-880CV) Page 224 of 2025

9

510(k) Premarket Notification

Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

System:	SSH-880CV
Transducer:	PST-30SBT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | | | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | P | | | P | P | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer:K090158

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Arshad D. Oth

(Division Sign Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vjtro Diagnostic Device Evaluation and Safety

510K1257

10

5 10(k) Premarket Notification

Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

| System: _

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	SSH-880CV
Transducer:	PST-50BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtime
3D) |
|------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----|-----------|------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | | P | | | |
| Cardiac Pediatric | P | P | P | P | P | P | P | | P | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K090158

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

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MAY 2012

11

510(k) Premarket Notification Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

System:	SSH-880CV
Transducer: PST-65AT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | | P | | | |
| Cardiac Pediatric | P | P | P | P | P | P | P | | P | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer:K090158

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

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Division of Radiological Devices Office of In Vitro Diagnosuc Device Evaluation and Safety 1 .510K

12

510(k) Premarket Notification Aplio Artida TM(v3.0) SSH-880CV Ultrasound System

SSH-880CV System: Transducer: PLT-704SBT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	THI	Dynamic
Flow	Power	TDI	CHI
2D	4D
(Realtime
3D)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)	P	P	P		P	P	P	P	P
Musculo-skeletal (Superficial)	P	P	P		P	P	P	P	P
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	P	P	P	P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer:K090158

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

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Division of Radiciogical Devices Office of In, Vitro Diagnostic Device Evaluation and Safety

510K Kla1577

13

510(k) Premarket Notification Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

SSH-880CV System: Transducer:_ PC-20M

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtime
3D) |
|------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----|-----------|------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | P | | | | | | | | |
| Cardiac Pediatric | | | | P | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | P | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer:K090158

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

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14

510(k) Premarket Notification Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

SSH-880CV System: Transducer:_ PST-25BT

.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtim-
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | E | E | E | E | E | E | E | | | E | E | |
| Cardiac Pediatric | E | E | E | E | E | E | E | | | E | E | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

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510(K): Aplio Artida v3.0 (SSH-880CV) Page 230 of 2025

MAY 2012

15

510(k) Premarket Notification . Aplio Artida TM(v3.0) SSH-880CV Ultrasound System

System:	SSH-880CV
Transducer:	PVT-375BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtime
3D) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | E | E | E | | E | E | E | E | E | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | E | E | E | | E | E | E | E | E | | | | |
| Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

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Division of Raciological Devices Office of in Vitro Diagrisstic Device Evaluation and Safety 510K

.

16

510(k) Premarket Notification Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

System:	22H-880CV
Transducer: ---------------------------------------------------------------------------------------------------------------	PLT-704AT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)*	THI	Dynamic
Flow	Power	TDI	CHI
2D	4D
(Realtime
3D)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	E	E	E		E	E	E	E	E
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

MhDOK
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(Division Sign-Off) Division of Radiological Devices Office of In Vijro Diagnostic Device Evaluation and Safety 1

ffice of In Vitro Diagnostic Device Evaluation and ...)

510K. K121577

17

510(k) Premarket Notification Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

System: _ SSH-880CV Transducer:_ PET-508MA

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | E | E | E | E | E | E | E | | | E | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

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ETOK

510(K): Aplio Artida v3.0 {SSH-880CV} Page 233 of 2025

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18

510(k) Premarket Notification Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

System:	SSH-880CV
Transducer:	PET-510MB

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtim
3D) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | E | E | E | E | E | E | E | | | E | E | E | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

(Division Sign-Off)

Division of Radiological Devices Office of In Vityo Diagnostic Device Evaluation and Safety

510K

19

510(k) Premarket Notification Aplio Artida ™(v3.0) SSH-880CV Ultrasound System

System:	SSH-880CV
Transducer:	PET-512MC

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | E | E | E | E | E | E | E | | | E | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer:K 103629

*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

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Y T 510K