ACUSON X800 Diagnostic Ultrasound System

K180067 · Siemens Medical Solutions USA, Inc. · IYN · Feb 7, 2018 · Radiology

Device Facts

• Record ID: K180067
• Device Name: ACUSON X800 Diagnostic Ultrasound System
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Feb 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The ACUSON X800 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal 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

ACUSON X800 is a mobile, software-controlled diagnostic ultrasound system. It transmits and receives ultrasound echo data, displaying images in B-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Color M Mode, Doppler Tissue Mode, Amplitude Doppler, and Harmonic Imaging. Operated by clinicians in clinical settings, the system provides real-time visualization and anatomical measurements. It integrates features from the ACUSON S family and SC2000 platforms, including tissue harmonic imaging, panoramic imaging, auto-measurements (eSie OB), spatial compounding, and elasticity imaging. Output is displayed on a 21-inch monitor with a 12-inch touch screen. Clinicians use these outputs adjunctively with other medical data to support clinical diagnosis. The device benefits patients by providing non-invasive, real-time diagnostic imaging and quantitative data for various clinical applications.

Clinical Evidence

Bench testing only. No clinical studies were required to support substantial equivalence as the device utilizes the same technology and principles as existing, cleared diagnostic ultrasound systems. Compliance with safety and performance standards (e.g., IEC 60601-1, ISO 10993-1, AIUM/NEMA UD-2/UD-3) was verified through independent evaluation.

Technological Characteristics

Multi-purpose diagnostic ultrasound system. Materials tested to ISO 10993-1. Sensing principle: ultrasonic pulsed echo/Doppler. Connectivity: DICOM, DICOM SR, wireless, TeamViewer. Software: proprietary, reused from S Family/SC2000 platforms. Safety standards: UL 60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37. Form factor: mobile system with 21-inch FPD and 12-inch touch screen.

Indications for Use

Indicated for fetal, abdominal, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, vascular, musculoskeletal, and peripheral vascular ultrasound imaging and anatomical measurements in patients requiring diagnostic ultrasound assessment.

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

• ACUSON S family (K172162)
• ACUSON SC2000 (K170315)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313

February 7, 2018

#### Re: K180067

Trade/Device Name: ACUSON X800 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 8, 2018 Received: January 9, 2018

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: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D 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) | K180067 |
|--------------------------|------------------------------------------|
| Device Name | ACUSON X800 Diagnostic Ultrasound System |

**Indications for Use**

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

**Indications for Use (Describe)**
The ACUSON X800 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal 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.

| Type of Use (Select one or both, as applicable) | <div><span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D)</div> <div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|

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FORM FDA 3881 (7/17) Page 1 of 1

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#### 510 (k) Number (if known)

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| | | | | | | Mode of Operation | | | | | |
|-------------------------------|---|---|---|-----|-----|-------------------|---------------------------|--------------------------|--------------------|-----------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler Imaging | Color Velocity (Specify) | Combined (Specify) | Other (Specify) | |
| Ophthalmic | N | N | N | N | N | N | | | | | |
| Fetal | N | N | N | N | N | N | | BMDC | | | |
| Abdominal | N | N | N | N | N | N | | BMDC | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | N | N | N | N | N | N | | BMDC | | | |
| Pediatric | N | N | N | N | N | N | | BMDC | | | |
| Small Organ (Note 1) | N | N | N | N | N | N | | BMDC | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | N | N | N | N | N | N | | BMDC | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | N | N | N | N | N | N | | BMDC | | | |
| Transvaginal | N | N | N | N | N | N | | BMDC | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | N | N | N | N | N | N | | BMDC | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | | BMDC | | | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | | BMDC | | | |
| Other (specify) | | | | | | | | | | | |

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## 510 (k) Number (if known):

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| | | | | | | | lode of Operation | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|---|---|-------------------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--|
| Clinical Applicatio | A | B | M | ama | CMD | ിയമായിരുന്നു. അവലംബം വാഹ്യമായി വാഹ്യമായി വിവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവുമായി വി | əpnildir. İstinadlar Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniya Rəmaniy | Color Color magino magino | (Alınada) Qırğında (Misadiya (Aliyanın Qaranması) (Ali Alınması) (Ali Alınması) (Ali Alınması) (Ali Alınması) (Ali Alınması) (Ali Alınması) (Ağrıq (Ağaqlıqları) (Ağrıqları | വിവിധ വാലയി | |
| Ophthalmic | | | | | | | | | | | |
| Firste Fi | | N | N | N | | N | N | | BMDC | | |
| Abdomina | | N | N | N | | N | N | | BMDC | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | N | N | N | | N | N | | BMDC | | |
| Miran Millia Newsloader Perfallance Shafe Organization Note Organization Note of Granie Note of Granderic Note of Grander of Gran | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophagea | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvagina | | | | | | | | | | | |
| Transurethra | | | | | | | | | | | |
| Infravascular | | | | | | | | | | | |
| Peripheral vesse | | | | | | | | | | | |
| | | | | | | | | | | | |
| ിലെ മുസ്ത്രിക്കുന്നു. അവലംബം കുറിച്ചിത്രത്തിന്റെ സ്വീത കുറിച്ച് തുടങ്ങിയ സംഭവിക്കുന്നു. അവലംബം കാലാവും സംരക്ഷേത്രം പ്രവരിച്ചുകൊണ്ടുകയും വിശ്വാസ്ത്രിക്കുന്നു. പിട്ടുള്ളത്തിലെ | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| Other (specify | | | | | | | | | | | |
| Device Name: | DAX Curved Array Transducer | | | | | | | | | | |
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |
| Ophthalmic | | | | | | | | | BMCD | | |
| Fetal | | N | N | N | N | N | | | BMCD | | |
| Abdominal | | N | N | N | N | N | | | BMCD | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | N | | | N | N | | BMCD | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Device Name: 5C1 Curved Array Transducer<br>Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | Color<br>Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| | A | B | M | PWD | CWD | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | N | N | N | N | N | | BMCD | | | | |
| Abdominal | N | N | N | N | N | | BMCD | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | | BMCD | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Device Name: | 9C3 Curved Array Transducer | | | | | | | | | | |
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| | Mode of Operation | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | N | N | N | N | N | N | N | |…