ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K132654 |
|---|---|
| Device Name | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. Ultrasound Gro |
| Product Code | IYO · Radiology |
| Decision Date | Sep 26, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | AI/ML, Pediatric, 3rd-Party Reviewed |
Intended Use
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Device Story
The Acuson SC2000 is a mobile, software-controlled diagnostic ultrasound system. It acquires harmonic ultrasound echo data via various transducers to display B-Mode, M-Mode, Pulsed/Continuous Wave Doppler, Color Doppler, Color Power Doppler, 3D, and 4D imaging. Used in clinical settings by physicians/technicians, it supports ECG synchronization for cardiac imaging. The system includes measurement and calculation packages (e.g., eSie Measure, syngo Mitral Valve Assessment, syngo Velocity Vector Imaging) to assist clinicians in evaluating pathology. It features Clarify Vascular Enhancement technology to improve tissue boundary detection and reduce acoustic clutter. Output is displayed on a flat panel; data may be used adjunctively for diagnosis. Benefits include enhanced visualization of anatomy and physiology, workflow acceleration, and support for intraoperative guidance.
Clinical Evidence
Bench testing only. The device underwent extensive safety and performance verification, including compliance with UL 60601-1, IEC 60601-2-37, and AIUM/NEMA UD-2/UD-3 standards. Biocompatibility was verified per ISO 10993-1. No clinical data was required for this 510(k) submission.
Technological Characteristics
Mobile ultrasound system with flat panel display. Transducers: 9L4, 6C1HD, V5M, 4V1c, 8V3, CW2, 10V4, 4Z1c, AcuNav 8F/10F, SoundStar 10F. Technologies: SpaceTime resolution control, Native Tissue Harmonic Imaging, MultiHertz frequency imaging, REST enhanced resolution, Native TEQ dynamic technology, Clarify VE vascular enhancement, Cadence CPS. Connectivity: DICOM (Print, Storage, Structured Reporting), Wireless Network. Safety: IEC 60601-1, IEC 60601-2-37, ISO 10993-1.
Indications for Use
Indicated for adult, pediatric, neonatal, and fetal patients requiring ultrasound imaging or fluid flow analysis of cardiac, vascular, abdominal, musculoskeletal, and cranial structures. Contraindications: None stated.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- Acuson SC2000 Diagnostic Ultrasound System (K072365)
- Acuson SC2000 Diagnostic Ultrasound System (K102017)
- Acuson SC2000 Diagnostic Ultrasound System (K113179)
- Acuson SC2000 Diagnostic Ultrasound System (K123622)
- Acuson SC2000 Diagnostic Ultrasound System (K130754)
- Acuson S2000 (K111674)
- Acuson S2000 (K072786)
Related Devices
- K162221 — ACUSON SC2000 Diagnostic Ultrasound System · Siemens Medical Solutions Inc. Ultrasound Group · Sep 6, 2016
- K142628 — Acuson SC2000 Diagnostic Ultrasound System · Siemens Medi Cal Solutions, Inc. · Oct 10, 2014
- K123622 — ACUSON · Siemens Medical Solutions USA, Inc. · Dec 5, 2012
- K112596 — ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Sep 16, 2011
- K102017 — SC2000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Sep 20, 2010
Submission Summary (Full Text)
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SC2000 Ultrasound System 510(k) Submission
#### Siemens Medical Solutions. Inc. Ultrasound Division
#### 510(k) Summary Prepared July 26, 2013
| Sponsor: | Siemens Medical Solutions, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043 |
|----------|-------------------------------------------------------------------------------------------------------------------------|
|----------|-------------------------------------------------------------------------------------------------------------------------|
Contact Person: Patrick J. Lynch (650) 694-5658 Telephone: (650) 694-5580 Fax:
July 26, 2013 Submission Date:
Acuson SC2000™ Diagnostic Ultrasound System Device Name:
Common Name: Diagnostic Ultrasound System
#### Classification:
Requiatory Class: ll Review Category: Tier II Classification Panel: Radiology
Ultrasonic Pulsed Doppler Imaging System FR # 892.1550 Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer Diagnostic Intravascular Catheter
FR # 892.1560 FR # 892.1570 FR # 870.1200
Product Code 90-IYN Product Code 90-IYO Product Code 90-1TX Product Code OBJ
#### A. Legally Marketed Predicate Devices
The Acuson SC2000™ Ultrasound System in this 510k is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K072365, K102017, K113179, K123622 and K130754.
#### B. Device Description:
The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode. Color Doppler Mode. Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
The SC2000™ Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat Panel Display. There is an available off-line workstation (SC2000WP)
SC2000 510(k) Submission
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#### C. Intended Use
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac. Pediatric. Transesophageal. Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:
#### Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardlac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physlology as well as visualization of other devices in the heart of adult and pediatric patients.
The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
#### Vascular Imaging Applications and Analysis
The system transmits uttrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding analomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
#### Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the dlastolic and systolic capture of ultrasound images.
#### Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.
#### Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
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## D. Substantial Equivalence
The submission device is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K072365, K072786, K102017, K113179, K123622 and K130754 with regard to both intended use and technological characteristics.
| Description | Acuson<br>SC2000™<br>K123622 | Acuson<br>S2000<br>K111674 | Acuson<br>S2000<br>K072786 | Acuson<br>SC2000™<br>This<br>submission |
|---------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------|----------------------------|-----------------------------------------|
| System | | | | |
| Hardware Safety - EN60601-1 Certified | X | X | X | X |
| Software Safety - EN60601-4 Certified | X | X | X | X |
| Acoustic Thermal Safety - EN60601-2-37 Certified | X | X | X | X |
| Transducers | | | | |
| See Table in Section 4.4.1.4 - All previously cleared | X | X | X | X |
| Biocompatibility - Same transducers no new materials | X | X | X | X |
| 6C1HD Transducer | X | X | X | X |
| AcuNav 8F/10F | X | X | X | X |
| AcuNav V | X | X | X | X |
| Soundstar 10F | X | X | X | X |
| Biocompatibility - Same transducers no new materials | X | X | X | X |
| Accessories | | | | |
| Respirometer | X | X | X | X |
| AcuNav Joystick | X | X | X | X |
| Imaging | | | | |
| SpaceTime™ resolution control | X | X | X | X |
| Native™ Tissue Harmonic Imaging | X | X | X | X |
| MultiHertz multiple frequency imaging | X | X | X | X |
| REST™ enhanced resolution imaging format | X | X | X | X |
| Output display standard compliance | X | X | X | X |
| Native TEQ™ dynamic ultrasound technology | X | X | X | X |
| TEQ™ ultrasound technology | X | X | X | X |
| TEQ™ technology for Spectral PW and CW Doppler | X | X | X | X |
| Dual screen and live dual imaging | X | X | X | X |
| Acoustic clip capture | X | X | X | X |
| eSie Measure Workflow Acceleration | X | X | X | X |
| Preset functionality with preset ordering and grouping<br>capabilities and linking to MultiHertz™ multiple frequency<br>Imaging | X | X | X | X |
| Integrated Stress echo capability | X | X | X | X |
SC2000 510(k) Submission
ﻢ ﻣ
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## Siemens Medical Solutions, Inc. Ultrasound Division
# SC2000 Ultrasound System
| DTI™ Doppler tissue imaging includes the following color<br>Doppler capabilities: | x | x | X | X |
|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------------|
| DTI Velocity (DTV) | X | X | X | X |
| Color Doppier Harmonic capability in DTI | x | . X | X | X |
| High Frame Rate Tissue Doppler (HTD) Capability | × | X | × | × |
| DTI Energy (DTE) | x | X | x | × |
| | X | × | x | X |
| Color Doppler Velocity (CDV) | × | x | X | X |
| Color Harmonic imaging | X | × | × | X |
| DTI Pulsed Wave (DTI PW) capability | X | × | X | X |
| Color Doppler M-Mode for: | × | | X | X |
| CDV | | X | | X |
| DTV | x<br>X | ×<br>X | ×<br>X | X |
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| | | X | X | x |
| Cadence™ contrast pulse sequencing technology (CPS)<br>PrecisonBurst programmable triggering for contrast agent | × | | | |
| destruction | X | X | × | X |
| TEQ and NTEQ ultrasound technology for Cadence™ CPS | × | × | × | X |
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| Cardiac calculations package | × | | | X |
| Slope Line calculations | X | | | X |
| Generic Calculations/Ratio function | × | | | X |
| avascular imaging package direct on | ,<br>ક વિદ્યાર | | 155 - 1 | ,如此时 |
| B-mode, M-mode, NTHI, CPS, PW Doppler, Triplex imaging<br>and High Resolution Color Flow (HRCF) | X | X | x | X |
| Cadence™ CPS Capture | x | X | X | × |
| Advanced SieClear™ spatial compounding with Dynamic TCE<br>TM (tissue contrast enhancement) technology | × | X | × | × |
| Advanced Vascular Analysis report package | X | X | × | × |
| Clarify™ Vascular Enhancement Technology | | ਮ | × | × |
| Linear and Vector imaging formals | X | X | × | × |
| Auto Doppler option | × | × | × | X |
| Time averaged velocity (TAV) calculation | x | X | x | X |
| Vascular Calculation package | X | × | × | X |
| Transcranial imaging | × | × | × | X |
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| syngo® Mitral Valve Assessment | X | x | × | × |
| syngo® auto Ejaction Fraction technology | X | X | × | X |
| D1ART with syngo® fourSight™ TEE view | X | x | x | X |
| syngo® Quantitative Synch Tools™ technology (QST) | × | × | X | X |
| syngo® Velocity Vector Imaging™ technology (VVI) rotation | X | × | × | × |
| syngo® ACQ auto-tracking contrast quantification | X | × | × | × |
SC2000 510(k) Submission
Page 10 of 32
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## ·Siemens Medical Solutions, Inc. Ultrasound Division
### SC2000 Ultrasound System 510(k) Submission
| Wireless Network Connectivity | X | | | X |
|-------------------------------|---|---|---|---|
| DICOM Print Service | X | X | X | X |
| DICOM Media Storage Service | X | X | X | X |
| DICOM Structured Reporting | X | X | X | X |
#### Technological Comparison
The new feature, Clarify VE, or Clarify is the same feature used on the S2000 (K072786). Clarify vascular enhancement technology uses power flow information to enhance Bmode tissue resolution and reduce acoustic clutter throughout the region of interest. Clarify also provides clearer vessel wall definition, improves tissue boundary detection and tissue contrast resolution, while preserving spatial resolution.
#### Similarities
As can be seen from the comparison table and the device description above, the modified device has substantially equivalent indications for use and technological characteristics as the predicate devices ACUSON \$2000 (K111674, 072786) and ACUSON SC2000 (K113179)
#### Differences
There are no differences for the new transducer (6C1HD) and feature (Clarify VE) from its use in S2000.
#### SC2000 510(k) Submission
Page 11 of 32
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K132654
Page 6 of 6
SC2000 Ultrasound System 510(k) Submission
#### E. Performance Data
The SC2000™is designed, verified, and validated according to the company's design control process and has been subjected to extensive safety and performance testing before release. Final testing of the SC2000 included various safety and performance testing designed to ensure the device meets all of its specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards including:
The Acuson SC2000™ has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment ■
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment I
- AIUM/NEMA UD-3. Standard for Real Time Display of Thermal and Mechanical ■ Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound ..
- Safety and EMC Requirements for Medical Equipment .
- IEC 60601-1 .
- IEC 60601-1-1 .
- IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power 세
- ISO 10993-1 Biocompatibility 해
#### F. Summarv
Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the SC2000 systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
SC2000 510(k) Submission
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Image /page/6/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of an eagle, with three lines forming the body and wings. The eagle is facing to the right.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Golf Silver Spring, MD 20993-0002
September 26, 2013
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K132654
Trade/Device Name: Acuson SC2000" Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX and OBJ Dated: August 21, 2013 Received: September 4, 2013
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRFI docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the Acuson SC2000" Diagnostic Ultrasound System, as described in your premarket notification:
#### Transducer Model Numbers
| 9L4 | 6C1I:ID | V5M |
|------|---------|------|
| 4V1c | 8V3 | CW2 |
| 4Z1c | V7M | 10V4 |
AcuNay 8F and 10F Ultrasound Catheter ACUSON AcuNay™ V 10F Ultrasound Catheter SoundStar 10F Ultrasound Catheter
{7}------------------------------------------------
Page 2-Mr. Job
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara.
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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#### 510(k) Number (if known): K132654
#### Device Name:
SC2000™ Diagnostic Ultrasound System
#### Indications for Use:
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:
#### Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW), Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intraluminal visualization of cardiac and great vessel analomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
The system transmits ultrasound energy from either a transesophageal approach in adult and pediatric patients; and from a transthoracic approach in neonatal and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PV) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
### Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms, legs and abdomen; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
#### Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
{9}------------------------------------------------
#### Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.
#### Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)
Mechal D. OHara
Division Sign-Off -Office of In Vitro Diagnostic Devices Division of Radiological Health (DRH)
K132654 510(k)_
Page 1 of 14
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510(k) Number (if known):
Device Name: SC2000 Diagnostic Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>3D | Other:<br>Real<br>Time<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P^a | P | | P |
| Abdominal | | P | P | P | P | P | P | | P^a | P | | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P^a | P | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P^a | P | P | P |
| Small Organ<br>(specify) | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | P^a | P | | |
| Cardiac | | P | P | P | P | P | P | | P^a | P | P | P |
| Trans-esophageal | | P | P | P | P | P | | | P^a | | P | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intra-Luminal | | P | P | P | P | P | P | | P^a | | | P |
| Peripheral Vessel | | P | P | P | P | P | P | P | P^a | P | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P^a | P | | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | P | P^a | P | | |
| Other (Neonatal<br>Cardiac) | | P | P | P | P | P | P | | P^a | P | | |
| Other (Intra-<br>Cardiac) | | P | P | P | P | P | P | | P^a | | | P |
N=new indication. P = Previously Cleared in 510(k) K072365, K 102017, K 113179
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
Division Sign-Off -Office of In Vitro Diagnostic Devices
510(k) -
{11}------------------------------------------------
510(k) Number (if known):
Device Name:
9L4
Indications for Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | P | P | P | P | | P | P | P | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | | P | P | P | P* | P |
| Musculo-skeletal<br>Superficial | P | P | P | P | | P | P | P | P* | P |
| Other (specify) | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler、B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) . Prescription Use (Per 21 CFR 801.109)
Division Sign-Off -Office of In Vitro Diagnostic Devices
510(k)__
Page 3 of _ 14
{12}------------------------------------------------
510(k) Number (if known):
Device Name:
#### 6C1HD
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | |
| Abdominal | | P | P | P | P | P | P | | P* | P | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P | |
| Intraoperative | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | |
| Small Organ<br>(specify) | | P | P | P | P | P | P | | P* | P | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other<br>(Abdominal<br>Vascular) | | P | P | P | P | P | P | | P* | P | |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
Division Sign-Off -Office of In Vitro Diagnostic Devices 510(k)_
Page 4 of _ 14
{13}------------------------------------------------
VSM
510(k) Number (if known):
Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | | | P* | | P | |
| Small Organ<br>(specify) | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | | | P* | | P | |
| Trans-esophageal | P | P | P | P | P | P | | | P* | | P | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K072365, K 102017, K 113179
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
Division Sign-Off -Office of In Vitro Diagnostic Devices
510(k)_ 100 million and the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the
{14}------------------------------------------------
510(k) Number (if known): '
Device Name:
4V1c
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Neonatal<br>Cardiac) | | P | P | P | P | P | P | | P* | P |
N=new indication. Previously Cleared in 510(k) K072365, K102017, K113179
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color, Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
Division Sign-Off -Office of In Vitro Diagnostic Devices
510(k)___
Page 6 of 14
{15}------------------------------------------------
510(k) Number (if known):
8V3
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows;
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | |
|----------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P * | P | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P * | P | |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal<br>Cephalic<br>Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P * | P | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | |…
