(29 days)
Not Found
No
The document describes a standard ultrasound system and does not mention any AI or ML capabilities in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a "Diagnostic Ultrasound System" intended for "visualization" and "imaging" to "display" data and provide "information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." It does not mention any therapeutic capabilities or functions to treat conditions, but rather to diagnose them.
Yes
The device description explicitly states, "The ACUSON X800 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system." The "intended use" section also mentions that the system's calculation packages "provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."
No
The device description explicitly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and describes its function as transmitting and receiving ultrasound echo data, which requires hardware components (transducers, processing units, etc.) beyond just software.
Based on the provided information, the ACUSON X800 ultrasound imaging system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body. The ACUSON X800 is a diagnostic ultrasound system that uses sound waves to create images of structures within the body.
- The intended use and device description clearly state it's for imaging internal anatomical structures. It's used for visualizing organs, vessels, and other tissues directly on the patient.
- There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, the ACUSON X800 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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, 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.
Product codes
IYN, IYO, ITX
Device Description
The ACUSON X800 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Parts, Transcranial, OB/GYN (visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular.
Additionally, it measures anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Since the ACUSON X800 Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACUSON S family (K172162), ACUSON SC2000 (K170315)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17) Page 1 of 1
3
510 (k) Number (if known)
:əsri bəpləyir.
Əsli bərəkət və qalında qalında qalında qalındığı və bir və qalındığı və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və
:swollo នន (bod ពេទ្យាល័យ ទីក្រុង ១០ នាទទួល ១០២ ប្រការ ប្រពា្រ 10 ព្រហែស្រីប្រ
| 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) |
AQ = how = presidentive = = president wen = M
Note for example: breast, testes, thyroid, penns, prostate, etc
A market me more and motions no and more and services and tow on assistem tow on assession
Concertion of CORPO, Office of In Villo Diagnostic Devices (OIVI
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
ຂອງເບອປີ ວ່າໄຊວັດເຖີຣໄປ ອງໄປ ປີ ປີ ປີ ອວຖືກົO - ກິO-ການເວົ້າ ແດ່ເຂົ້າກ່ຽ 500(x)
4
510 (k) Number (if known):
:əsri bəbinə aid bitki növü. İstinadlar Respublikasının Filmin Filmin Film Səsinə Qaran Film
:swollot se ybod nemud adj to eisylsnis wolf birll 10 priismi burosanil r
| 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 | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | N | BMCD | ||||||
| Small Organ | |||||||||||
| (Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) | |||||||||||
| Device Name: 5C1 Curved Array Transducer | |||||||||||
| Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||
| Clinical Application | Mode of Operation | Color | |||||||||
| Amplitude | |||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (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 | |||||||||||
| (Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Mode of Operation | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | ||||
| Abdominal | N | N | N | N | N | N | N | BMCD | |||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | N | N | BMCD | |||||
| Small Organ | |||||||||||
| (Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | N | N | N | N | N | BMCD | |||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | N | N | N | N | N | N | BMCD | ||||
| Small Organ (Note 1) | N | N | N | N | N | N | BMCD | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | N | N | N | BMCD | |||||||
| Musculo-skeletal Conventional | N | N | N | BMCD | |||||||
| Musculo-skeletal Superficial | N | N | N | BMCD | |||||||
| Other (specify) | |||||||||||
| Device Name: | 14L5 Linear Array Transducer | ||||||||||
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | Other | |||||||||
| (Specify) | |||||||||||
| A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | |||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | N | N | ||||||
| Small Organ | |||||||||||
| (Note 1) | N | N | N | N | N | BMCD | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | N | N | N | N | N | BMCD | |||||
| Peripheral vessel | N | N | N | N | N | BMCD | |||||
| Laparoscopic | N | N | N | N | N | BMCD | |||||
| Musculo-skeletal | |||||||||||
| Conventional | N | N | N | N | N | BMCD | |||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | BMCD | |||||
| Abdominal | N | N | N | N | N | BMCD | |||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | N | N | N | N | N | BMCD | |||||
| Pediatric | N | N | N | N | N | BMCD | |||||
| Small Organ | |||||||||||
| (Note 1) | N | N | N | N | N | BMCD | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | N | N | N | N | N | BMCD | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | N | N | N | N | N | BMCD | |||||
| Musculo-skeletal | |||||||||||
| Superficial | N | N | N | N | N | BMCD | |||||
| Other (specify) | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | N | N | N | N | N | ||||||
| Transrectal | N | N | N | N | N | BMCD | |||||
| Transvaginal | N | N | N | N | N | BMCD | |||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) | |||||||||||
| Device Name: 5V1 Phased Array Transducer | |||||||||||
| Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||
| Clinical Application | A | B | M | Mode of Operation | Other (Specify) | ||||||
| PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | ||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | N | N | ||||||
| Small Organ (Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | BMCD | |||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler Imaging | Color Velocity (Specify) | Combined (Specify) | Other (Specify) | |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | BMCD | ||||||
| Abdominal | N | N | N | BMCD | |||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | N | N | BMCD | |||||
| Small Organ (Note 1) | N | BMCD | |||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | BMCD | |||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| (Specify) | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | ||||||||||
| Small Organ | |||||||||||
| (Note 1) | N | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | ||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal |
A = half-indication; B = solid object
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Additional Comments:
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500(K)
5
510 (k) Number (if known):
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Additional Comments:
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510 (k) Number (if known):
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Adbitional Comments:
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Additional Comments:
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PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PAGE IF NECESSARY
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8
510 (k) Number (if known):
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Additional Comments:
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510 (k) Number (if known):
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVID)
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510 (K) Mumber (if known):
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A = new holicaling, P = previously cleared by FDA
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Noter For Eximele: bioyunda səslər, thyoru, parısı, prostate, etc.
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11
510 (k) Number (if known):
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ultrasound imaging, for fluid flow analysis of the human body as follows:
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Additional Comments:
Note 1
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12
510 (k) Number (if known):
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510 (k) Number (if known):
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510 (k) Number (if known):
A = new indication; P = previously cleared by FDA Other (specify)
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Additional Comments:
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15
510(k) Summary
| Date: | Nov 22, 2017 | ||
|---|---|---|---|
| 1. Sponsor: | Siemens Medical Solutions USA, Inc., | ||
| Ultrasound Division | |||
| 685 East Middlefield Road | |||
| Mountain View, California 94043 | |||
| Contact Person: | Sulgue Choi | ||
| Tel: (425) 281-9898 | |||
| 2. Device Name: | ACUSON X800 Diagnostic Ultrasound System | ||
| Common Name: | Diagnostic Ultrasound System with Accessories | ||
| Classification: | Regulatory Class: II | ||
| Review Category: Tier II | |||
| Classification Panel: Radiology | |||
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | |
| Diagnostic Ultrasound Transducer | 892.1570 90-ITX | ||
| Manufacturing Site: | Jabil Inc. | ||
| 3800 Giddings Road, | |||
| Auburn Hills, Michigan, 48326, UNITED STATES |
3. Legally Marketed Predicate Devices
The ACUSON X800 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the company's own products, the ACUSON S family (K172162) and ACUSON SC2000 (K170315).
4. Device Description
The ACUSON X800 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.
16
5. 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.
6. Summary of Technological Characteristics
The ACUSON X800 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the company's own products, the ACUSON S family (K172162) and ACUSON SC2000 (K170315) with regard to both intended use and technological characteristics. Both the subject ultrasound system and the predicate ultrasound systems function in the same manner as all diagnostic ultrasound systems and transducers.
The foundation of the ACUSON X800 is the S Family with features and transducers integrated with the ACUSON X800 hardware and the ACUSON X800 reuse software developed for S Family and SC2000 platforms as well as some transducers from S Family with a cost reduced connector.
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
| Feature / Characteristic | ACUSON X800
This Submission | ACUSON S family
S1000/S2000/S3000
K# 172162 | ACUSON SC2000
K# 170315 | |
|--------------------------------------|-------------------------------------------------|---------------------------------------------------|---------------------------------------------------|----------------------------|
| Indications for Use:
■ Fetal | √ | √ | -- | |
| ■ Abdominal | √ | √ | -- | |
| ■ Pediatric | √ | √ | -- | |
| ■ Small Organ | √ | √ | -- | |
| ■ Cardiac | √ | √ | -- | |
| ■ Transrectal | √ | √ | -- | |
| ■ Transvaginal | √ | √ | -- | |
| ■ Peripheral vessel | √ | √ | -- | |
| ■ Musculo-skeletal
(conventional) | √ | √ | -- | |
| ■ Musculo-skeletal
(superficial) | √ | √ | -- | |
| Frequencies Supported: | (1.0MHZ18MHz) | (2.0MHz17MHz) | -- | |
| Modes:
■ B | √ | √ | -- | |
| ■ M | √ | √ | -- | |
| ■ PWD (Pulsed Wave
Doppler) | √ | √ | -- | |
| Feature / Characteristic | ACUSON X800
This Submission | ACUSON S family
S1000/S2000/S3000
K# 172162 | ACUSON SC2000
K# 170315 | |
| ■ | CWD (Continuous Wave
Doppler) | √ | √ | -- |
| ■ | PW DTI (Doppler Tissue
Image) | √ | √ | -- |
| ■ | Color Doppler | √ | √ | -- |
| ■ | Power Doppler | √ | √ | -- |
| ■ | Combined (BMDC) | √ | √ | -- |
| | Features: | | | |
| ■ | Native™ tissue harmonic
imaging | √
(Harmonic imaging) | √ | -- |
| ■ | SieScape™ panoramic
imaging | √
(Panoramic imaging) | √ | -- |
| ■ | Color SieScape™
panoramic imaging | √
(Color Panoramic
imaging) | √ | -- |
| ■ | TEQ™ ultrasound
technology | √
(Auto TEQ) | √ | -- |
| ■ | Cardiac Imaging
physiological signal display | √ | √ | -- |
| ■ | syngo ® Auto OB
measurements | √
(eSie OB) | √ | -- |
| ■ | Advanced SieClear™
spatial compounding | √
(Compounding) | √ | -- |
| ■ | Cadence contrast agent
imaging | √
(Contrast imaging) | √ | -- |
| ■ | Clarify™ vascular
enhancement technology | √
(Clarify) | √ | -- |
| ■ | eSie™ Touch elasticity
imaging | √
(Virtual Touch - Strain) | √ | -- |
| ■ | syngo ® Velocity Vector
Imaging | √ | √ | -- |
| ■ | Semi Auto-segmentation
(eSie Calc) | √
(eSie Calc) | √ | -- |
| ■ | Custom Tissue Imaging /
Speed of Sound | √
(Speed of Sound) | √ | -- |
| ■ | eSie Fusion | √
(Fusion) | √
(S3000 only) | -- |
| ■ | VTq | √
(Virtual Touch - pSWE) | √
(S2000 & S3000 only) | -- |
| ■ | VTIQ | √
(Virtual Touch - SWE) | √
(S2000 & S3000 only) | -- |
| ■ | DTCE/RTIE | √
(UltraArt) | √ | -- |
| | Feature / Characteristic | ACUSON X800
This Submission | ACUSON S family
S1000/S2000/S3000
K# 172162 | ACUSON SC2000
K# 170315 |
| ■ | MMR (Multi-Modality
Review) | √
(Modality Compare) | √ | -- |
| ■ | HD Zoom | √ | √ | -- |
| ■ | eSieScan | √
(Protocols) | √ | -- |
| ■ | InFocus | √
(InFocus) | -- | √ |
| ■ | MBD Burst | √
(Flash sequencing) | √ | -- |
| ■ | Freestyle activating
transducer | √
(Gesture control) | -- | -- |
| ■ | TeamViewer | √
(TeamViewer) | √ | -- |
| ■ | Contrast Agent Image | √
Motion Stabilized
Persistence | √ | -- |
| ■ | DICOM | √
(DICOM) | √ | -- |
| ■ | DICOM SR | √
(DICOM SR) | √ | -- |
| Wireless | | √ | √ | -- |
| | Monitor: 21" FPD | √
(OLED) | √ | -- |
| Touch Screen: 12" Touch
Screen | | √
(15" adjustable Touch
Screen) | √ | -- |
| Output Display Standard
(Track 3) | | √ | √ | -- |
| | Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 | -- |
| | UL 60601-1 Certified | √ | √ | -- |
| | Indications for Use | √ | √ | -- |
17
18
7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards. The systems comply with the following voluntary standards:
- 피 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
- I IEC 62359, Test methods for the determination of thermal and mechanical indices
- Safety and EMC Requirements for Medical Equipment 로
19
- o ANSI/AAMI ES 60601-1
- o IEC 60601-1
- o IEC 60601-1-2
- o IEC 60601-2-18
- o IEC 60601-2-37
- I ISO 10993-1 Biocompatibility
8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the ACUSON X800 Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence.
9. Summary
Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Requlation 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 system has accumulated a long history of safe and effective performance. Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON X800 system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.