7410 Ultrasound System (MyLabSigma)
Device Facts
| Record ID | K191072 |
|---|---|
| Device Name | 7410 Ultrasound System (MyLabSigma) |
| Applicant | Esaote, S.p.A. |
| Product Code | IYN · Radiology |
| Decision Date | Jun 10, 2019 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
MyLabSigma is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.
Device Story
Portable ultrasound system (MyLabSigma) with handle; uses mechanical/electronic probes (convex, linear, phased array, Doppler) to acquire ultrasound signals. Transforms inputs into B-mode, M-mode, Doppler, Color Flow, Tissue Velocity Mapping, 3D/4D images. Operated by clinicians in clinical settings. Features include Auto NT (nuchal translucency) and Auto EF (ejection fraction) measurements. Output displayed on LCD touchscreen; assists in diagnosis, biopsy guidance, and catheter/needle placement. Benefits include improved diagnostic visualization and procedural guidance.
Clinical Evidence
No clinical tests were performed. Bench testing included acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety. Software validation performed per FDA guidance; ergonomics, usability, and image quality evaluated and found equivalent to predicate/reference devices.
Technological Characteristics
Portable ultrasound system; LCD color display; capacitive touchscreen. Supports phased, linear, Doppler, and volumetric probes. Connectivity: wireless. OS: Windows 10 Enterprise LTSB. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, NEMA UD-2, NEMA UD-3.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intraoperative, laparoscopic, pediatric, small organ, neonatal, cephalic, transvaginal, musculoskeletal, urological, cardiovascular, and peripheral vascular applications. Includes needle/catheter guidance and nerve blocks. No specific age/gender contraindications stated.
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
- 7410 - MyLabGamma (K161359)
Reference Devices
- 6420 - MyLabX5 (K183191)
- 6440 - MyLab9 (K173291)
Related Devices
- K191663 — Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 · Canon Medical Systems Corporation · Sep 18, 2019
- K260673 — LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power · GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 24, 2026
- K221089 — P12 Elite Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Sep 15, 2022
- K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 18, 2017
- K200001 — MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 9, 2020
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 10, 2019
Esaote S.p.A. % Piet de Jong Regulatory Affairs Manager Via Enrico Melen 77 Genova. 16152 ITALY
Re: K191072
Trade/Device Name: 7410 Ultrasound System (MyLabSigma) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 18, 2019 Received: May 13, 2019
Dear Piet de Jong:
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
{1}------------------------------------------------
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)
K191072
Device Name
7410 Ultrasound System (MyLabSigma)
Indications for Use (Describe)
MyLabSigma is intended to perform diagnostic general ultrasound studies including:
Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal,
Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional),
Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric,
Transoesophageal (cardiac), Peripheral Vessel.
The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.
| 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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{3}------------------------------------------------
#### 7410
| | Mode of Operations | | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|--|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P | P: 5, 6 | |
| Abdominal | P | P | P | P | P | P | P | | P | P: 5, 6 | |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | P: 5 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | P: 5 | |
| Small Organs [1] | P | P | P | P | P | P | P | | P | P: 5 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 5 | |
| Adult Cephalic | P | P | P | P | P | P | P | | P | P: 5 | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P [7] | P: 5 | |
| Transesophageal (Cardiac) [2] | P | P | P | P | P | P | P | P | P | P: 5 | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | | P | P: 5, 6 | |
| Transvaginal | P | P | P | P | P | P | P | | P | P: 5, 6 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5 | |
| Laparoscopic | P | P | P | P | P | P | P | | P | P: 5 | |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | | P | P: 5 | |
| Musculo-skeletal<br>Superficial [3] | P | P | P | P | P | P | P | | P | P: 5 | |
| Other (Urological) | P | P | P | P | P | P | P | | P | P: 5, 6 | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border
Previously cleared via K142008, K161359 and to be cleared with this submission
{4}------------------------------------------------
| 1) | AC2541 |
|-----|----------|
| 2) | IH 6-18 |
| 3) | IL 4-13 |
| 4) | L 3-11 |
| 5) | L 4-15 |
| 6) | LP 4-13 |
| 7) | mC 3-11 |
| 8) | P2 3-11 |
| 9) | S2MCW |
| 10) | S5MCW |
| 11) | SB2C41 |
| 12) | SB3123 |
| 13) | SC3123 |
| 14) | SE3133 |
| 15) | SHFCW |
| 16) | SI2C41 |
| 17) | SL1543 |
| 18) | SL2325 |
| 19) | SL3116 |
| 20) | SL3235 |
| 21) | SL3323 |
| 22) | SL3332 |
| 23) | SP2730 |
| 24) | ST2612 |
| 25) | TLC 3-13 |
{5}------------------------------------------------
# AC2541
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | |
|-----------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5 |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P: 5 |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardial border
Previously cleared viaK142077 and K161359
{6}------------------------------------------------
#### IH 6-18
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|-----------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|--|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5 | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 | |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardial border
Previously cleared via K161359
{7}------------------------------------------------
## IL 4-13
| Clinical Application | Mode of Operations | | | | | | | | | | |
|-----------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|--|
| | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic Imaging<br>(TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5 | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Other (Urological) | | | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnT) in Adult Cardiac for left ventrice opacification of the left ventricular endocatial border
Previously cleared via K161359
{8}------------------------------------------------
## L3-11
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| | | | | | | Mode of Operations | | | | | | |
|-------------------------------|---|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|--|--|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler<br>(PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic Imaging<br>(TEI) | Other (specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5 | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 7, 8, 10 | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 | | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5, 7, 8 | | |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | P: 5, | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5, 7 | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5, 7, 8 | | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | | P | P: 5, 7, 8 | | |
| Other | | | | | | | | | | | | |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventrice opacification of the left ventricular endocardial border
Previously cleared via K173291
{9}------------------------------------------------
## L4-15
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | |
|-------------------------------|--------------------|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 7, 10, |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5, |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5, 7 |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | P: 5, |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5, 7 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5, 7, 8 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | | P | P: 5, 7, 8, |
| Other | | | | | | | | | | |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardial
Previously cleared via K173291 and to be cleared with this submission
{10}------------------------------------------------
#### LP 4-13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler<br>(PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic Imaging<br>(TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | P | P | P | | P | P | P | | P | P: 5 |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal<br>Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardial border
Previously cleared via K142008, K161359 and to be cleared with this submission
{11}------------------------------------------------
#### mC 3-11
| | Mode of Operations | | | | | | | | | |
|-----------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | |
| Small Organs [1] | P | P | P | | P | P | P | | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border
Previously cleared via K173291 and to be cleared with this submission
{12}------------------------------------------------
# P2 3-11
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|-----------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|--|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | P 5 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | P 5 | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P 5 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | | |
| Musculo-skeleta1 Superficial [3] | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular . .. 1 - - - - 1 : 1 1 : - .. 1 - ..
Previously cleared via K173291 and to be cleared with this submission
{13}------------------------------------------------
#### S2MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|-------------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping<br>(TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | P | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | P | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal<br>Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventrication and visualization of the left ventricular endocardial border
Previously cleared via K142077 and K161359
{14}------------------------------------------------
#### S5MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler<br>(PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic Imaging<br>(TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | P | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal<br>Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardial border
Previously cleared via K142008 and K161359
{15}------------------------------------------------
## SB2C41
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | | | | | | | | | | |
|-------------------------------------|---|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5, 6 |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 6 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal<br>Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardial border
Previously cleared via K142077 and K161359
{16}------------------------------------------------
#### SB3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| | | Mode of Operations | | | | | | | | | | |
|-------------------------------------|---|--------------------|-----|-----|---------------|---------------------------|--------------|-------------------------------------|---------------------------|-----------------|--|--|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping<br>(TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5, 6 | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardi…
