ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System
Device Facts
| Record ID | K202683 |
|---|---|
| Device Name | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 15, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, 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.
Device Story
The ACUSON Sequoia is a multi-purpose, software-controlled diagnostic ultrasound system. It transmits ultrasound energy into the body and receives echoes to produce images of anatomical structures and fluid flow. The system operates by vibrating ceramics within a transducer to emit high-frequency sound waves; these waves reflect off tissue density boundaries and return as echoes. The system processes these signals to display 2D, M-Mode, Pulsed/Continuous Wave Doppler, Color Doppler, and 3D/4D volume images. Used in clinical settings by trained medical professionals, the device provides anatomical measurements and calculation packages. These outputs are used adjunctively with other clinical data to assist in diagnosis. The system supports various transducers and catheter-based imaging for cardiac and vascular anatomy. The device benefits patients by providing non-invasive, real-time visualization of internal structures and blood flow, aiding in the evaluation of pathology.
Clinical Evidence
No clinical data was generated for this submission. The substantial equivalence is based on the fact that the devices use the same technology and operating principles as their respective predicate devices. The expanded labeling for lung ultrasound imaging is supported by clinical literature.
Technological Characteristics
The system uses high-frequency ultrasound waves (above audible range) for imaging. It utilizes various transducers (curved, linear, phased array, mechanical 3D, continuous wave, and transesophageal). It supports B-Mode, M-Mode, PW/CW Doppler, Color Doppler, and 3D/4D imaging. Biocompatibility conforms to ISO 10993-1. The system is software-controlled and supports DICOM standards.
Indications for Use
Indicated for fetal, abdominal, pediatric, neonatal cephalic, small parts, OB/GYN, cardiac, pelvic, vascular, musculoskeletal, and peripheral vascular imaging and measurement by trained healthcare professionals.
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 Sequoia (K201462)
- ACUSON SC2000 (K200585)
- ACUSON Freestyle (K200644)
- ACUSON S1000, S2000, S3000 (K172162)
- ACUSON P200 (K191922)
- ACUSON P500 (K163396)
- ACUSON NX3, NX3 Elite (K192835)
- ACUSON Juniper (K201130)
Reference Devices
- Philips Affiniti Diagnostic Ultrasound System Series (K201012)
Related Devices
- K041319 — SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jun 7, 2004
- K051139 — ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · May 13, 2005
- K063085 — MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Nov 14, 2006
- K032114 — SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jul 21, 2003
- K142628 — Acuson SC2000 Diagnostic Ultrasound System · Siemens Medi Cal Solutions, Inc. · Oct 10, 2014
Submission Summary (Full Text)
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October 15, 2020
Image /page/0/Picture/1 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. % Ms. Christine Dunbar Senior Regulatory Affairs Specialist 22010 South East 51st Street ISSAQUAH WA 98029
## Re: K202683
Trade/Device Name: ACUSON Sequoia Diagnostic Ultrasound System. ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System, ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite 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, OBJ, LLZ, OIJ Dated: September 11, 2020 Received: September 15, 2020
Dear Ms. Dunbar:
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
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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 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 medical devices and radiation-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) K202683
Device Name
ACUSON Sequoia Diagnostic Ultrasound System
#### Indications for Use (Describe)
The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
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510 (k) Number (if known):
Device Name:
Intended Use:
#### ACUSON Sequoia Diagnostic Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | 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<br>(Note 1) | | P | P | P | | P | P | | BMDC | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | |
| Adult Cephalic | | P | P | P | | P | P | | BMDC | |
| Cardiac | | P | P | P | P | P | P | | BMDC | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Volume Imaging |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K200707
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(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: | 4V1 Phased Array Transducer | | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | | |
| Abdominal | P | P | P | P | | P | P | | BMDC | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | BMDC | | |
| 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) | | | | | | | | | | | |
N = new indication; P = previously cleared by K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(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:<br>Intended Use: | | | | | | DAX Curved Array Transducer<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | |
|----------------------------------|-------------------|---|---|-----|-----|--------------------------------------------------------------------------------------------------------|----------------------|------------------------------|-----------------------|--------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | 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<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) | | | | | | | | | | |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(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:
#### 5C1 Curved Array Transducer
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | 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<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) | | | | | | | | | | |
N = new indication; P = previously cleared by K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(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:
#### 9C3 Curved Array Transducer
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | 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<br>(Note 1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMCD | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(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:<br>Intended Use: | 18L6 Linear Array Transducer<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | | Mode of Operation | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMCD | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMCD | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| 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 K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(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: | 14L5 Linear Array Transducer | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMCD | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMCD | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | 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 K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(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: 10L4 Linear 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 | | | | | | | | | | |
| 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<br>(Note 1) | | P | P | P | | P | P | | BMCD | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMCD | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | 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 K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(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: Intended Use:
#### 9EC4 Endocavity Transducer Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(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 | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(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: | 5V1 Phased Array Transducer | | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | BMCD | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | | P | P | | BMCD | | |
| Cardiac | P | P | P | P | P | P | P | | BMCD | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(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:<br>Intended Use: | | | | | | | | 8V3 Phased Array Transducer | | | | |
|----------------------------------|-------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| | 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) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMCD | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMCD | | | |
| Small Organ<br>(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 | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(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:<br>Intended Use: | CW2 Continuous Wave Transducer<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | Mode of Operation | | | | | | | | | |
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | |…
