MYLABSEVEN, MYLABALPHA
Device Facts
| Record ID | K142008 |
|---|---|
| Device Name | MYLABSEVEN, MYLABALPHA |
| Applicant | Esaote, S.p.A. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 12, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Esaote's Model 6400 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 abdomninal, Laparoscopic and Other: Urologic. The 6400 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. Esaote's Model 7400 is a compact 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 abdomninal and Other: Urologic. The 7400 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
6400 (mainframe) and 7400 (compact) ultrasound systems; input from phased, convex, linear, and volumetric probes; transforms acoustic signals into B-mode, M-mode, Doppler, Color Flow Mapping, Amplitude Doppler, Tissue Velocity Mapping, 3D/4D, and harmonic imaging; used in clinical settings by physicians/technicians; output displayed on LCD; provides diagnostic imaging and guidance for biopsies, needle placement, and nerve blocks; upgrades include Quality Intima Media Thickness (QIMT) management, Elastosonography (ElaXto) qualitative analysis, and laparoscopic application (6400 only).
Clinical Evidence
No clinical tests were performed. Substantial equivalence is supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal/electromagnetic/mechanical safety testing per IEC and NEMA standards.
Technological Characteristics
Mainframe (6400) and portable (7400) ultrasound systems; LCD color display; wireless capability; battery-powered (7400); supports phased, convex, linear, and volumetric probes; modes: B, M, TEI, MView, Doppler, CFM, AD, TVM, 3D/4D; QIMT and ElaXto analysis; safety: IEC 60601-1, IEC 60601-2-37, NEMA UD-2, NEMA UD-3.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult and pediatric patients for cardiac, vascular, abdominal, fetal, small organ, musculoskeletal, and urological applications, including biopsy and needle placement guidance.
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
- 6400 (K111302, K132231, K132466)
- 7400 (K111302, K132231, K132466)
- 7340 (K081794, K091009, K110688)
- 6150 (K051308, K052805, K060827, K081386, K091009)
Related Devices
- K132231 — MYLABSEVEN, MYLABALPHA · Esaote, S.p.A. · Nov 27, 2013
- K091009 — MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 · Esaote, S.p.A. · May 18, 2009
- K161359 — 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System · Esaote, S.p.A. · Jul 19, 2016
- K132466 — MYLABSEVEN 6400, MYLABALPHA 7400 · Esaote, S.p.A. · Dec 4, 2013
- K111302 — MYLABSEVEN, MYLABALPHA · Esaote, S.p.A. · Jul 22, 2011
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 consists of a stylized depiction of an eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2014
Esaote S.p.A. % Ms. Allison Scott Senior Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268
Re: K142008
Trade/Device Name: 6400 and 7400 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 22, 2014 Received: July 23, 2014
Dear Ms. Scott:
This letter corrects our substantially equivalent letter of September 12, 2014.
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.
This determination of substantial equivalence applies to the following transducers intended for use with the 6400 & 7400 Ultrasound Systems, as described in your premarket notification:
Transducer Model Number- 6400
| SP2430 | SP2442 | LA435 |
|--------|--------|--------|
| LA523 | AL2442 | AL2443 |
| SL1543 | SL2325 | AC2541 |
| SC3123 | CA430 | S2MCW |
| S5MCW | SHFCW | S2MPW |
| SE3123 | EC1123 | TRT33 |
| ST2613 | ST2612 | IOT342 |
{1}------------------------------------------------
| IOT332 | IOE323 | LP323 |
|-------------------------------|--------|--------|
| BC431 | BC441 | SB2C41 |
| BE1123 | SB3123 | |
| Transducer Model Number- 7400 | | |
| SP2430 | SP2442 | AL2442 |
| AL2443 | SL1543 | SL2325 |
| AC2541 | SC3123 | S2MCW |
| S5MCW | SHFCW | S2MPW |
| SE3123 | EC1123 | ST2613 |
| ST2612 | IOT342 | SB2C41 |
| SB3123 | | |
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.
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.
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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,
Robert A Ochs
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
K142008
Device Name MyLabAlpha (7400), MyLabSeven (6400)
### Indications for Use (Describe)
Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatic, Small organs, Musculoskeletal (Conventional and Superlicial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, Laparoscopic and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric, Intraoperative abdominal and Other: Urologic. The 7400 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)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|----------------------------------|---------------------------|-----------------|
| Ophthalmic | P | P | P | P | P | P | P | | P | |
| 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 | P | P | P | P | P | P | P | | P | P: 5 |
| 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 | N | N | N | | P | N | N | | N | N: 5 |
| Musculo-skeletal Conventional | | 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 | P: 5 |
6400
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as foll
: New indication; P: Previously cleared by FDA; E:Added under
] Small Organs includes Breast, Thyroid and Testicle
| Cardiac is Adult and Pediatric
| Musculo Skeletal - Nerve Block
| Combined modes are: B+M+PW+CW+CW+CFM+PD
[5] Compound Imaging (Mview)
[6] 3D/4D
anc [7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification
visualization of the left ventricular endocardial border
Previously cleared via k111302,
K132231, K132466
escription Use Only Per 21 CFR 801 Part D Concurrence of CDF
Page 2 of 32
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### Pres
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and
Previously cleared via k111302,
K132231, K132466
[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
| tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | |
|--------------------------------------------------------------------------------------------|--------------------|---|-----|-----|---------------|------------------------|--------------|-------------------------------|------------------------|-----------------|
| Clinical Application | Mode of Operations | | | | | | | | | |
| | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | P | P | P | P | P | P | P | | P | P: 5, 6 |
| Fetal | P | P | P | P | P | P | P | | P | P: 5, 6 |
| 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 | P | P | P | P | P | P | P | | P | P: 5 |
| 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 (7) | 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: 5 |
| Transesophageal (Cardiac) [2] | P | P | P | P | P | P | P | | P | P: 5 |
| Transesophageal (Non Cardiac) | P | P | P | P | P | P | P | | P | P: 5, E: 6 |
| Transrectal | P | P | P | P | P | P | P | | P | P: 5, E: 6 |
| Transvaginal | P | P | P | P | P | P | P | | P | P: 5 |
| Transurethral | P | P | P | P | P | P | P | | P | P: 5 |
| Intravascular | P | P | P | P | P | P | P | | P | P: 5 |
| 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 | P | P | P | P | P | P | P | | P | P: 5 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | P: 5 |
| Other (Urological) | P | P | P | P | P | P | P | | P | P: 5 |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows 7400
Page 34 of 2406
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{6}------------------------------------------------
| | | | | | | Body as ronovs. | | | | |
|---------------------------------------------------------------------------|----|---|-----|-----|------------------|------------------------------|-----------------|----------------------------------|---------------------------|-----------------|
| Clinical Applicatio | ਸੂ | N | PWD | CWD | Color Doppler | mplitude Doppler (PD) | Combined [4] | issue Velocit) Lapping (TVM | Harmonic maging (TE) | Other (specif |
| Ophthalmic | | | | | | | | | | |
| Fetal | d | d | d | d | | | d | | | P: 5 |
| Abdominal | d | d | d | d | d d | d d | d | | മ്പ് | P: 5 |
| ntraoperative (Abdomina | | | | | | | | | | |
| ntraoperative Neurologic | | | | | | | | | | |
| Pediatric | d | d | d | d | d | d | d | | d | P: 5 |
| Small Organs [1 | | | | | | | | | | |
| Neonatal Cephalic Adult Cephalic | d | d | d | d | d | d | d | | d | 6:5 |
| | d | d | d | d | d | d | d | | d | P: 5 |
| Cardiac [2] Transesophageal (Cardi | d | d | d | d | d | d | d | d | P (7) | സ<br>். |
| | | | | | | | | | | |
| ransesophageal (Non Cardi | | | | | | | | | | |
| ransrecta | | | | | | | | | | |
| ransvagina | | | | | | | | | | |
| ransurethra | | | | | | | | | | |
| ntravascular | | | | | | | | | | |
| Peripheral Vascula | d | d | d | d | d | d | d | | d | സ<br>d |
| aparoscopic | | | | | | | | | | |
| Musculo-skeletal Convention<br>જિ | | | | | | | | | | |
| Musculo-skeletal Superfici: | | | | | | | | | | |
| Other (Urologica | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | P | | | | | | | | | |
| Scrotal | P | P | P | P | P | P | P | | | P: 5 |
| Abdominal | P | P | P | P | P | P | P | | | P: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | | P: 5 |
| 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 | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue 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) | | | | | | | | | | |
| Mode of Operations | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | P | P | P | | P | P | P | | P | P: 5 |
| 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 | 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] | 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) | | | | | | | | | | |
| N: New indication; P: Previously cleared by FDA; E:Added under Appendix E | | | | | | | | | | |
# SP2430 (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
US Small Organs includes Breast, Thyroid, etc.
[2] Cardiac is Adult and Pediatric
3) Musculo Skeletal - Nerve Block
[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)
[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and
visualization of the left ventricular endocardial border
Previously cleared via k132466
Page 35 of 2406
Page 4 of 32
{7}------------------------------------------------
Page 5 of 32
## escription Use Only Per 21 CFR 801 Part D Concurrence of CDRR
SP2442 (6400 and 7400 systems)
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo
M
E
N
U
[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
2) Cardiac is Adult and Pediatric :
[3] Musculo Skeletal - Nerve Block
[4] Combined models are D.M. DIV. CPU
[5] Compound Imaging (Mview)
Previously cleared via k13223
{8}------------------------------------------------
## escription Use Only Per 21 CFR 801 Part D Concurrence of CDRR
LA435 (6400 systems)
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo
App ру
CT Similar Organs Includes Breast, Thyroid and etc.
2) Cardiac is Adult and Pediatric
[32] Musculo Skeletal - Nerve Block
[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+CFM+PD
[5] Compound Imaging (Mview)
Previously cleared via K14067
Page 6 of 32
{9}------------------------------------------------
LA523 (6400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
N: New indication; P: Previously cleared by FDA; E:Added under Appendix
[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+CFM+PD
2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
A) Combined modes are: B+M; B+M+PW; B+M+PW+CFN
[5] Compound Imaging (Mview)
reviously cleared via K14067
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRF
Page 7 of 32
{10}------------------------------------------------
age 39 of 2406
Page 8 of 32
ription Use Only Per 21 CFR 801 Part D Concurrence of
| Intraoperative Neurological | | | | | | | |
|---------------------------------------------------------------------------|---|---|---|---|---|---|---|
| Pediatric | 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 | P | P | P | P | P | P | P |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P |
| Other (Urological) | | | | | | | |
| N: New indication; P: Previously cleared by FDA; E:Added under Appendix E | | | | | | | |
P: 5
P: 5
P: 5
.2442 (6400 and 7400 systems)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Deather
Other (specify)
Harmonic
Imaging (TEI)
Tissue Velocity
Mapping (TVM)
Amplitude | Combined | Doppler
Color
Doppler
CWD
PWD
M
в
Clinical Application
Ophthalmic
5 : d
S : ત
d d
ﮨﮯ ﮨﮯ۔
ﮨﻢ ﮨﮯ۔
ﻟﻪ ﮨﮯ
ﻟﻪ d
ﮨﮯ ۔ ﺍﻭﺭ
ﮨﻢ ﮨﮯ ﮨﮯ
ntraoperative (Abdominal
Abdominal Fetal
ം: 5 P: 5 P: 5
Small Organs includes Breast, Thyroid and Testicle
Cardiac is Adult and Pediatric
Musculo Skeletal - Nerve Block
Combined modes are: B+M+PW+CFM+PD
[3]
[4]
Musculo Skeletal - Nerve Block
Combined modes are: B+M+RW+CE
[4] Combined modes are: B+M+PW+CFM+F
Compound Imaging (Mviev
eviously cleared via k1414
{11}------------------------------------------------
Page 9 of 32
## Pr
| Research Use Only. Part D Contains: COOH |
|------------------------------------------|
| 21 CFR 801 Part D Contains: COOH |
Previously cleared via k132466
[5] Compound Imaging (Mview)
[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+CFM+PD
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
|-----------------------------------|---|---|-----|-----|---------------|------------------------|--------------|-------------------------------|------------------------|-----------------|
| Ophthalmic | P | P | P | | P | P | P | | P | P: 5 |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | E | | E | E: 5 |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | 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 [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) | | | | | | | | | | |
# AL2443 (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body
{12}------------------------------------------------
## rescription Use Only Per 21 CFR 801 Part D Concurrence of CDRR
| | | Mode of Operations | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------------|-----|-----|------------------|------------------------------|-----------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| 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] | 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) | | | | | | | | | | |
| Mode of Operations | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>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) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | 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) | | | | | | | | | | |
| New indication: P: Previously cleared by FDA; E: Added under Appendix E | | | | | | | | | | |
| cended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | 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 | 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 |
| I: New indication; P: Previously cleared by FDA; E:Added under Appendix E | | | | | | | | | | |
| SC3123 (6400 and 7400 systems)<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<br>Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other |
| Ophthalmic | | | | | | | | | | |
| Fetal | E | E | E | | E | E | E | | E | |
| Abdominal | E | E | E | | E | E | E | | E | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | E…
