ACUSON P200 Diagnostic Ultrasound System
Device Facts
| Record ID | K191922 |
|---|---|
| Device Name | ACUSON P200 Diagnostic Ultrasound System |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 15, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (superficial) 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
Multi-purpose mobile diagnostic ultrasound system; transmits/receives ultrasound echo data; displays B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Color M, Doppler Tissue, Amplitude Doppler, and harmonic imaging. Operated by clinicians in clinical environments. Integrates hardware/software from ACUSON X800, Juniper, and S3000 platforms. Provides anatomical measurements and calculation packages (e.g., eSie OB, eSie Left Heart, eSie Measure, eSie Follicle, Stress Echo). Output displayed on 13.3" touchscreen; assists physicians in clinical diagnosis by providing adjunctive data. Benefits include non-invasive visualization and quantification of anatomical structures and blood flow.
Clinical Evidence
No clinical data submitted. Substantial equivalence supported by bench testing, including acoustic output measurements (AIUM/NEMA UD-2/UD-3), thermal/mechanical index characterization (IEC 62359), and electrical/EMC safety testing (IEC 60601 series). Biocompatibility verified per ISO 10993-1.
Technological Characteristics
Mobile ultrasound system; 1.0MHz-18MHz frequency range; 13.3" touchscreen. Patient contact materials tested to ISO 10993-1. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-37 (ultrasound). Features include harmonic imaging, compounding, UltraArt, TEQ, biopsy, and various automated measurement packages (eSie series).
Indications for Use
Indicated for fetal, abdominal, pediatric, small parts, OB/GYN, adult/pediatric/neonatal cardiac, pelvic, neonatal cephalic, musculoskeletal, and peripheral vascular ultrasound imaging and measurement in clinical settings.
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 X800 (K180067)
- ACUSON S3000 (K183575)
- ACUSON Juniper (K180039)
Related Devices
- K210743 — ACUSON Redwood Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Apr 1, 2021
- K193257 — ACUSON Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Jan 31, 2020
- K130619 — ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Mar 21, 2013
- K201462 — ACUSON Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Jun 24, 2020
- K112646 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Oct 12, 2011
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114
August 15, 2019
## Re: K191922
Trade/Device Name: ACUSON P200 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 17, 2019 Received: July 18, 2019
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
## 510(k) Number (if known) K191922
Device Name ACUSON P200 Diagnostic Ultrasound System
#### Indications for Use (Describe)
The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (superficial) 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) Number (if known):
Device Name:
### ACUSON P200 Diagnostic Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | BMDC | |
| Abdominal | P | P | P | | P | P | BMDC | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | BMDC | |
| Small Organ (Note 1) | P | P | P | | P | P | BMCD | |
| Neonatal Cephalic | P | P | P | | P | P | BMCD | |
| Adult Cephalic | | | | | | | | |
| Cardiac | P | P | P | P | P | P | BMCD | |
| Trans-esophageal | P | P | P | P | P | P | BMCD | |
| Transrectal | P | P | P | | P | P | BMCD | |
| Transvaginal | P | P | P | | P | P | BMCD | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | P | P | P | P | P | P | BMCD | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | | P | P | BMCD | |
| Musculo-skeletal<br>Superficial | P | P | P | | P | P | BMCD | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067; K180039; K187357
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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510 (k) Number (if known):
Device Name: Intended Use:
#### 4V1 Phased Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | BMDC | |
| Abdominal | P | P | P | | P | P | BMDC | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | BMDC | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067
For example: Breast, Thyroid, Testis Note 1 Note 2 For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{5}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### 5V1 Phased Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | BMCD | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | P | P | P | P | P | P | BMCD | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067
Note 1
Note 2
For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{6}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### 8V3 Phased Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | P | BMCD | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | BMCD | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | P | P | P | P | P | P | BMCD | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{7}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### 10V4 Curved Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | P | BMCD | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | BMCD | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | BMCD | |
| Adult Cephalic | | | | | | | | |
| Cardiac | P | P | P | P | P | P | BMCD | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K183575
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{8}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### CW2 Continuous Wave Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | | | | P | | | | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | P | | | | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K183575
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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510 (k) Number (if known):
#### CW5 Continuous Wave Transducer
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | | | | P | | | | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | P | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K183575
Note 1 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous Note 2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{10}------------------------------------------------
510 (k) Number (if known):
#### 10L4 Linear Array Transducer
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | BMCD | |
| Abdominal | P | P | P | | P | P | BMCD | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | BMCD | |
| Small Organ (Note 1) | P | P | P | | P | P | BMCD | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | P | P | P | | P | P | BMCD | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | | P | P | BMCD | |
| Musculo-skeletal<br>Superficial | P | P | P | | P | P | BMCD | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067
Note 1 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous Note 2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{11}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### 14L5 Linear Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | BMCD | |
| Small Organ (Note 1) | P | P | P | | P | P | BMCD | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | P | P | P | | P | P | BMCD | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | | P | P | BMCD | |
| Musculo-skeletal<br>Superficial | P | P | P | | P | P | BMCD | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{12}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### 18L6 Linear Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | BMCD | |
| Small Organ (Note 1) | P | P | P | | P | P | BMCD | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | | P | P | BMCD | |
| Musculo-skeletal<br>Superficial | P | P | P | | P | P | BMCD | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{13}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### 5C1 Curved Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | BMCD | |
| Abdominal | P | P | P | | P | P | BMCD | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | BMCD | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{14}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### 9C3 Curved Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | BMCD | |
| Abdominal | P | P | P | | P | P | BMCD | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | BMCD | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Trans-esophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | | P | P | BMCD | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{15}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### 9EC4 Endocavity Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Trans-esophageal | | | | | | | | |
| Transrectal | P | P | P | | P | P | BMCD | |
| Transvaginal | P | P | P | | P | P | BMCD | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K180067
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{16}------------------------------------------------
510 (k) Number (if known):
Device Name:
#### V5Ms Multiplane TEE Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Trans-esophageal | P | P | P | P | P | P | BMCD | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vessel<br>(Note 2) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | |
| Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA K183575
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{17}------------------------------------------------
K191922
### 510(K) SUMMARY
| Date: | August 1, 2019 | | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------|--------|
| 1. Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043 | | |
| Contact Person: | HyunJung Lee<br>Tel: (425) 281-5061 | | |
| 2. Device Name: | ACUSON P200 Diagnostic Ultrasound System | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | |
| Classification: | Regulatory Class:<br>Review Category:<br>Classification Panel: | II<br>Tier II<br>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: | Siemens Healthineers Ltd.<br>2nd ~ 3rd Floor, 143, Sunhwan-ro, Jungwon-gu, Seongnam-si,<br>Gyeonggi-do, Republic of Korea | | |
## 3. Legally Marketed Predicate Devices
The ACUSON P200 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the company's own ACUSON X800 (K180067) which is the primary predicate device.
The additional predicates are the indications for Neonatal Cephalic and Trans-esophageal uses which are cleared under ACUSON S3000 (K183575) and eSie Left Heart, eSie Measure, eSie Follicle and Stress Eco under ACUSON Juniper (K180039) as described in the table of section 6 Summary of Technological Characteristics.
{18}------------------------------------------------
## 4. Device Description
The ACUSON P200 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. M-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.
## 5. Intended Use
The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures). Adult. Pediatric and Neonatal Cardiac. Pelvic. Neonatal Cephalic. Vascular. Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) 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 P200 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 X800 (K180067). ACUSON Juniper (K180039) and ACUSON S3000 (K183575) with regards 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 P200 is the ACUSON X800 with features and transducers integrated with the ACUSON X800 hardware and the ACUSON P200 reuse software developed for X800 mainly as well as some transducers from Juniper and S3000 with a connector.
| Feature / Characteristic | | ACUSON P200<br>Subject device | ACUSON X800<br>K180067 | ACUSON<br>Juniper<br>K1180039 | ACUSON S3000<br>K183575 |
|--------------------------------------|-----------------------------------------|-------------------------------|-------------------------------|-------------------------------|-------------------------|
| | Indications for Use: | | | | |
| ■ | Fetal | √ | √ | | |
| ■ | Abdominal | √ | √ | | |
| ■ | Pediatric | √ | √ | | |
| ■ | Small Organ | √ | √ | | |
| ■ | Cardiac | √ | √ | | |
| ■ | Neonatal Cephalic | √ | | | √ |
| ■ | Trans-esophageal | √ | | | √ |
| ■ | Transrectal | √ | √ | | |
| ■ | Transvaginal | √ | √ | | |
| ■ | Peripheral vessel | √ | √ | | |
| ■ | Musculo-skeletal<br>(conventional) | √ | √ | | |
| Feature / Characteristic | ACUSON P200<br>Subject device | ACUSON X800<br>K180067 | ACUSON<br>Juniper<br>K1180039 | ACUSON S3000<br>K183575 | |
| ■ | Musculo-skeletal (superficial) | √ | √ | | |
| | Frequencies Supported: | √<br>(1.0MHZ~18MHz) | √<br>(1.0MHZ~18MHz) | | |
| | Modes: | | | | |
| ■ | B | √ | √ | | |
| ■ | M | √ | √ | | |
| ■ | PWD (Pulsed Wave Doppler) | √ | √ | | |
| ■ | CWD (Continuous Wave<br>Doppler) | √ | √ | | |
| ■ | PW DTI (Doppler Tissue<br>Image) | √ | √ | | |
| ■ | Color Doppler | √ | √ | | |
| ■ | Power Doppler | √ | √ | | |
| ■ | Combined (BMDC) | √ | √ | | |
| | Features: | | | | |
| ■ | Harmonics | √ | √ | | |
| ■ | Compounding | √ | √ | | |
| ■ | UltraArt Universal Image<br>processing | √ | √ | | |
| ■ | Tissue Equalization (TEQ) | √ | √ | | |
| ■ | Biopsy | √ | √ | | |
| ■ | Clarify | √ | √ | | |
| ■ | Cardiac Imaging | √ | √ | | |
| ■ | Speed of Sound | √ | √ | | |
| ■ | Protocols | √ | √ | | |
| ■ | DICOM | √ | √ | | |
| ■ | eSie Calcs | √ | √ | | |
| ■ | Wireless | √ | √ | | |
| ■ | Virtual Touch Strain Imaging | √ | √ | | |
| ■ | Virtual Touch Point Shear<br>Wave (VTQ) | √ | √ | | |
| ■ | Virtual Touch Shear Wave<br>(VTIQ) | √ | √ | | |
| ■ | Contrast Agent Imaging | √ | √ | | |
| ■ | eSie OB | √ | √ | |…
