MyLabSix Ultrasound System
Device Facts
| Record ID | K161168 |
|---|---|
| Device Name | MyLabSix Ultrasound System |
| Applicant | Esaote Europe B.V. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 2, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Device Story
MyLabSix is a mainframe ultrasound system for diagnostic imaging and fluid flow analysis. It processes inputs from various ultrasound probes (phased, convex, linear, Doppler, volumetric) to produce real-time images. The system features B-Mode, Amplitude Doppler, Tissue Enhancement Imaging, Multi View, Tissue Velocity Mapping, Color Flow Mapping, Pulse Wave Doppler, and 3D/4D modes. Operated by clinicians in clinical settings, it includes a height-adjustable keyboard and dual LCD displays (one with touch screen). The upgrade adds motorized probe management for 3D/4D volumetric acquisition, laparoscopic application support, needle visibility enhancement, and an on-board 'MyLibrary' tutorial feature. Output is used by physicians to guide biopsies, assist needle placement, and perform diagnostic studies, potentially improving procedural accuracy and patient outcomes.
Clinical Evidence
No clinical tests were performed. Substantial equivalence is supported by bench testing, including acoustic output measurement, biocompatibility, and electrical/mechanical safety testing per IEC and NEMA standards.
Technological Characteristics
Mainframe ultrasound system with LCD displays and touch-screen control panel. Supports phased, convex, linear, Doppler, and volumetric probes. Connectivity via LAN/USB for digital storage. Conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound safety), and ISO 10993 (biocompatibility). Features include Needle Visibility, MyLibrary tutorial, and motorized probe management for 3D/4D acquisition.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of human body including cardiac, transesophageal cardiac, peripheral vascular, neonatal/adult cephalic, small organs, musculoskeletal (conventional/superficial), abdominal, fetal, transvaginal, transrectal, pediatric, intraoperative abdominal, laparoscopic, and urologic applications. Includes biopsy guidance and needle placement assistance for vascular/anatomical structures and peripheral nerve blocks.
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
- 6420 - MyLabSix (K141486)
Reference Devices
- 6400 - MyLabSeven (K142008)
- 8100 - MyLabOne (K101605)
- SonoSite Edge (K113156)
Related Devices
- K141486 — MYLABSIX ULTRASOUND SYSTEM · Esaote Europe B.V. · Jul 11, 2014
- K162290 — MyLabSix CrystaLine · Esaote, S.p.A. · Oct 14, 2016
- K070903 — MYLAB40 · Esaote Europe B.V. · Jul 2, 2007
- K173291 — 6440 Ultrasound System · Esaote, S.p.A. · Jan 12, 2018
- K071996 — MYLAB30, MODEL 7300 · Esaote, S.p.A. · Aug 3, 2007
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2016
Esaote Europe B.V. % Allison Scott, RAC Managing Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268
Re: K161168
Trade/Device Name: MyLabSix Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 1, 2016 Received: August 2, 2016
Dear Ms. Scott:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
K161168
Device Name
MyLabSix Ultrasound System
### Indications for Use (Describe)
Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
| 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}------------------------------------------------
Prescription Use Only Per 21 CFR 801 Part D Concurrence
DRH, Office of In Vitro Diagnostics and Radiological Health
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|---------------|------------------------|--------------|------------------------------|------------------------|-----------------|
| Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Transesophageal (Non Cardiac) | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Transrectal | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Transvaginal | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Transurethral | P | P | P | P | P | P | P | P | P | N: 5 N/A |
| Intravascular | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Laparoscopic | N | N | N | N | N | N | N | N | N | N: 5 N/A |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| Other (Urological) | P | P | P | P | P | P | P | P | P | P: 5 N/A |
| 5420 is already cleared via K141486 and to be cleared with this submission | | | | | | | | | | |
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F1/3D/4D
{4}------------------------------------------------
| SI2C41 | SL3116 | SE3133 | TLC 3-13 | IH 6-18 | IL 4-13 | LP 4-13 | SB3123 | SL3323 | SL3235 | SL2325 | SL3332 | SC3421 | AC2541 | SC3123 | SE3123 | AL2442 | SL1543 | SP2730 | S2MCW | S5MCW | SB2C41 | SHFCW | ST2612 | IOT342 |
|--------|--------|--------|----------|---------|---------|---------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|-------|-------|--------|-------|--------|--------|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 |
{5}------------------------------------------------
# Prescription Use Only Per 21 CFR 801 Part D Concurrence of
DRH, Office of In Vitro Diagnostics and Radiological Health (OlR
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| Ophthalmic | E | E | E | E | E | E | E | E | E | E: 5 |
| Fetal | E | E | E | E | E | E | E | E | E | E: 5 |
| Abdominal | E | E | E | E | E | E | E | E | E | E: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | E | E | E: 5 |
| Small Organs [1] | E | E | E | E | E | E | E | E | E | E: 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | E | E | E | E: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | E | E | E | E | E | E | E | E | E | E: 5 |
| Musculo-skeletal Superficial [3] | E | E | E | E | E | E | E | E | E | E: 5 |
| Other (Urological) | E | E | E | E | E | E | E | E | E | E: 5 |
| The SI2C41 probe is added | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | | P | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | E: 5 |
| Small Organs [1] | P | P | P | | P | P | P | | P | E: 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 | E: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | E: 5 |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | E: 5 |
| Other (Urological) | | | | | | | | | | |
| Mode of Operations | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | | E | | | E | | E | | E | E: 5 |
| Fetal | E | E | E | | E | E | E | | E | E: 5 |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | E | E | E | | E | E | E | | E | E: 5 |
| Transvaginal | E | E | E | | E | E | E | | E | E: 5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | E | E | E | | E | E | E | | E | E: 5 |
| *the SE3133 probe is added | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | E | E | E | | E | E | E | | | |
| Fetal | | | | | | | | | | E: 5 |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | E | E | E | | E | E | E | | E | E: 5 |
| Transvaginal | E | E | E | | E | E | E | | E | E: 5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | E | E | E | | E | E | E | | E | E: 5 |
| he TLC 3-13 probe is added und | | | | | | | | | | |
SI2C41
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as foll
The S12C41 probe is added under Appendix F and to be
under Appendix E and to be
N: New indication; P: Previously cleared by FDA; E:Added under Apper
Testicles and Prostate
Breast Studies
Thyroid Studies
Brain Scans
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[3] Musculo Skeletal - Nerve Block
[4] Cardiac is Auricular and Pendular
[4] Combined modes are: B+M+PW+CW+CFM+
[5] Compound Imaging (M-view)
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{6}------------------------------------------------
SL3116
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
The SESTTO probe is all cady
cleared via K101605 and added
under Appendix E
under Appendix E
under Appenda B
(1) Small Organs includes Breast, Thyroid etc.
(2) Cardiac is Adult and Pediatric
[32] Musculo Skeletal - Nerve Block
[4] Combined modes are: B-: B+: M-: M+: PW-: PW+: CV-: CV+
1.5 Compound Imaging (M-View)
[6] Includes contrast (CnTI) in Adult Cardiac for left ventricle o
INSPECTION OF LINE FOR VERTICAL BORD
AND HORIZONTAL BORD
REHABILITATION OF MYOCARDIAL INFARCTION PATIENTS
{7}------------------------------------------------
Prescription Use Only Per 21 CFR 801 Part D Concurrence of
CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo SE3133
under Appendix E and to be
cleared via this submission
N: New indication: P: Previously cleared by FDA: E:Added und
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2) Cardiac is Adult, Pediatric and Pediatric Cardiac
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+
[5] Compound Imaging (MView)
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[7]3D/4D
{8}------------------------------------------------
T L C 3-13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
The TLC 3-13 probe is added under
Appendix E and to be cleared via this submission
SUBMISSIONS
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[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M, PW+M, C+V
REC COMBINED INDEX (RCI) + TOTAL HIRS RAD
imaging (mview)
[6] Includes contrast (CTI) in Adult Cardiac fo
INCREASED CONTRAST FORM IN FINAL SURFACE FOR ISOLATION of the left ventricular endocardial border [5.1A]
DIVISION OF REAL ESTATE, PENNSYLVANIA DEPARTMENT
OF STATE
APPLICATION FOR REAL ESTATE SALESPERSON LICENSE
{9}------------------------------------------------
IH 6-18
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
|-----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| Ophthalmic | E | E | E | | E | E | E | | E | E: 5 |
| Fetal | E | E | E | | E | E | E | | E | E: 5 |
| Abdominal | E | E | E | | E | E | E | | E | E: 5 |
| Intraoperative (Abdominal) | E | E | E | | E | E | E | | E | E: 5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | E | | E | E: 5 |
| Small Organs [1] | E | E | E | | E | E | E | | E | E: 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | E | E | | E | E: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | E | E | E | | E | E | E | | E | E: 5 |
| Musculo-skeletal Superficial [3] | E | E | E | | E | E | E | | E | E: 5 |
| Other (Urological) | E | E | E | | E | E | E | | E | E: 5 |
| The IH 6-18 probe is added | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | E | E | E | E | E | E | E | E | E | E: 5 |
| Fetal | E | E | E | E | E | E | E | E | E | E: 5 |
| Abdominal | E | E | E | E | E | E | E | E | E | E: 5 |
| Intraoperative (Abdominal) | E | E | E | E | E | E | E | E | E | E: 5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | E | E | E: 5 |
| Small Organs [1] | E | E | E | E | E | E | E | E | E | E: 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | E | E | E | E: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | E | E | E | E | E | E | E | E | E | E: 5 |
| Musculo-skeletal Superficial [3] | E | E | E | E | E | E | E | E | E | E: 5 |
| Other (Urological) | | | | | | | | | | |
the IH 6-16 probe is added under Appendix E and to be
moner of 10 probe is and to be
under Appendix E and to be
cleared via this submission
अध्यक्ष र काम बनाने बाली बात
2018 - 12:44 PM Previous Provinsia Provinsia P
11 News March March Proved by Provinsia Provinsia B
13 News Market Marian Prove Corporation a
11. Small Organs includes Breast, Thyroid and more!
[2] Cardiac is Adult and Pediatric
3) Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+C
[S]-Compound Imaging Signal (MEAN) (Arbitrary)
CALCULATES COMPRESSOR VENT FACTOR FOR VENT LINE
Cardiovascular, Endocrine, Neurologic, Musculoskeletal, Pulmonary, Renal, Gastrointestinal, Hematologic, Immunologic, Dermatologic, Ocular, ENT, Dental, and Mental Disorders
border radial
and occular
centric
left of the
adaptation
realizes
{10}------------------------------------------------
Prescription Use Only Per 21 CFR 801 Part D Concurrence of
CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
under Appendix E and to be cleared via this submission
N: New indication; P: Previously cleared by FDA; E:Added under A
- **Breast**
- **Cancer**
- **Articles**
- **Including**
- **Ocean**
- **Small**
2) Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+
[5] Compound Imaging (Nview)
classed via antilation
11 Marcin Results Marceller
11 Marcula elemin Merceller
13 Marcula elemin Merce Marcel Marie Marie Maria Maria Marina and
13 Marcula Republican Particl
F1/3D/4D
{11}------------------------------------------------
_P 4-13
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as for
| Mode of Operations | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------|--------------------|----------|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | | N | N: 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 | N | N | N | | N | N | N | | N | N: 5 | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
| | | | | | | | | | | | |
| SB3123<br>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 (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | N | N | N | | N | N | N | | N | N: 5, 7 | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | N | N | N | | N | N | N | | N | N: 5, 7 | |
| Transvaginal | N | N | N | | N | N | N | | N | N: 5, 7 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | N | N | N | | N | N | N | | N | N: 5, 7 | |
| Mode of Operations | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | P: 5 | |
| 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: 5 | |
| Neonatal Cephalic | | P | P | | P | P | P | | P | P: 5 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | 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: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Other (Urological) | | | | | | | | | | | |
| the SL3323 probe is already | | | | | | | | | | | |
| Mode of Operations | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| 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 | |
| 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 | 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: | | | | | | Mode of Operations | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | E | | E | E: 5 | |
| Small Organs [1] | E | E | E | | E | E | E | | E | E: 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) |…
