APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K121577 |
|---|---|
| Device Name | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Toshiba Medical Systems Corporation, Japan |
| Product Code | IYN · Radiology |
| Decision Date | Jun 22, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Aplio Artida SSH-880CV V3.0 is a mobile diagnostic ultrasound system for cardiology and vascular imaging. It acquires 2D and 3D real-time cardiac images using linear, curved, or phased array transducers (2.5-7.5 MHz). The system features 3D Wall Motion Tracking (WMT) software, which analyzes myocardial movement from 3D image inputs. A new feature, Activation Imaging (AI), provides a strain display mode using color-coding to represent the arrival time to a defined strain value, with the color persisting after the threshold is reached. Operated by clinicians in clinical settings, the system provides visual output for diagnostic assessment of cardiac dyssynchrony. The device aids healthcare providers in evaluating myocardial function and timing, potentially improving diagnostic accuracy for cardiac conditions.
Clinical Evidence
Clinical evaluation conducted at an evaluation site to validate the Activation Imaging (AI) feature. Study included adult male and female subjects (ages 18+) scheduled for routine echocardiographic evaluation with dyssynchrony. Primary endpoint was the collection of images from 10 subjects to verify the provision of activation timing. Results met pass criteria; no adverse events reported.
Technological Characteristics
Mobile ultrasound system; console with color LCD display; transducers (linear, curved, phased array, 2.5-7.5 MHz). Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, AIUM-NEMA UD2, and AIUM-NEMA UD3 standards. Software includes 3D Wall Motion Tracking with Activation Imaging (AI) strain display mode. Quality system per 21 CFR 820 and ISO 13485.
Indications for Use
Indicated for cardiac, transesophageal, abdominal, and peripheral vascular studies in adult and pediatric populations.
Regulatory Classification
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.
Predicate Devices
- Toshiba APLIO ARTIDA MODEL SSH-880CV Ultrasound Diagnostic System (K090158)
Submission Summary (Full Text)
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# 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.
1. Submitter's Name: Toshiba America Medical Systems, Inc.
- 2. Address: 2441 Michelle Drive Tustin, CA 92780-2068
#### 3. Establishment Registration: 2020563
#### 4. Contact Person:
Charlemagne Chua
Manager Regulatory Affairs
(714) 730-5000
- 5. Submission Date May 30, 2012 (revised June 20, 2012)
## 6. Device Proprietary Name: APLIO ARTIDA MODEL SSH-880CV V3.0
- 7. 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.
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#### 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.
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#### 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.
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## 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 | |
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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)
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# 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)
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(Division Sign Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number Kla1577
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#### 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(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.
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#### 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal<br>(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
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# 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<br>(Tracks 3) | જિ | M | | PWD CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | | THI Dynamic<br>Flow | Power | .I.DI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(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
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#### 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(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
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(Division Sign Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vjtro Diagnostic Device Evaluation and Safety
510K1257
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# 5 10(k) Premarket Notification
Aplio Artida ™(v3.0) SSH-880CV Ultrasound System
| System: _<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | SSH-880CV |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Transducer: | PST-50BT |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(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
***(Division Sign-Off)***
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K
MAY 2012
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#### 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(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
(Division Sign-Off)
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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(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
(Division Sign-Off)
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<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal<br>(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
(Division Sign-Off,
Division of Radislegical Devices Office of In Vitro Diegnostic Device Evaluation and Safety 510K
{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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtim-<br>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<br>(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
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaiuation and Safety 510K
> 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(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
(Division sign On
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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |…
