MYLABGAMMA

K142077 · Esaote, S.p.A. · IYN · Sep 12, 2014 · Radiology

Device Facts

• Record ID: K142077
• Device Name: MYLABGAMMA
• 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 7410 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 and Other: Urologic. The 7410 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

The 7410 Ultrasound System is a portable, battery-powered diagnostic imaging device featuring an LCD color display and touchscreen interface with QWERTY emulation. It supports various transducer types, including phased, convex, linear, Doppler, and volumetric probes. The system processes ultrasound signals to generate images in B-Mode, M-Mode, Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), Tissue Enhancement Imaging (TEI), Multi View (MView), and 3D/4D modes. Used in clinical settings by healthcare professionals, the device provides real-time visualization for diagnostic studies, biopsy guidance, and needle placement for vascular access or nerve blocks. It includes digital storage and wireless network connectivity for data management. The output assists clinicians in anatomical assessment and procedural guidance, potentially improving diagnostic accuracy and procedural safety.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electromagnetic, and mechanical safety testing per recognized standards.

Technological Characteristics

Portable ultrasound system with LCD display and touchscreen. Supports phased, convex, linear, Doppler, and volumetric transducers. Modes: B, M, Doppler, CFM, AD, TVM, TEI, MView, 3D/4D. Battery-powered with wireless connectivity. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3. Manufactured under ISO 9001:2000 and ISO 13485 quality systems.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal/Adult Cephalic, Small organs, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, and Urologic studies. Includes guidance for biopsy, needle placement, 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

• 7400 (K111302, K132231, K132466)
• 6420 (K141486)

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 image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.

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: Trade/Device Name: 7410 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 31, 2014 Received: July 31, 2014

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.

This determination of substantial equivalence applies to the following transducers intended for use with the 7410 Ultrasound Systems, as described in your premarket notification:

| | Transducer Model Number | |
|--------|-------------------------|--------|
| SP2730 | AL2442 | SL1543 |
| SL2325 | SL3235 | SL3323 |
| SL3332 | AC2541 | SC3123 |
| SC3421 | S2MCW | S5MCW |
| SHFCW | SE3123 | ST2612 |
| SB2C41 | | |

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sm.7)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K142077

Device Name MyLabGamma (7410)

Indications for Use (Describe)

Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric and Other: Urologic. The 7410 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)

Page 1 of 18

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Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 2 of 18

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
|----------------------------------------------------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------------------------------------------------------------------|---------------|------------------------------|------------------------|-----------------|
| Ophthalmic | N | N | N | N | N | N | N | N | N | N: 5, 6 |
| Fetal | N | N | N | N | N | N | N | N | N | N: 5, 6 |
| Abdominal | N | N | N | N | N | N | N | N | N | N: 5 |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | N | N: 5 |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | N | N: 5 |
| Pediatric | N | N | N | N | N | N | N | N | N | N: 5 |
| Small Organs [1] | N | N | N | N | N | N | N | N | N | N: 5 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N: 5 |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N: 5 |
| Cardiac [2] | N | N | N | N | N | N | N | N | N | N: 5 |
| Transesophageal (Cardiac) [2] | N | N | N | N | N | N | N | N | N | N: 5 |
| Transesophageal (Non Cardiac) | N | N | N | N | N | N | N | N | N | N: 5 |
| Transrectal | N | N | N | N | N | N | N | N | N | N: 5 |
| Transvaginal | N | N | N | N | N | N | N | N | N | N: 5 |
| Transurethral | N | N | N | N | N | N | N | N | N | N: 5 |
| Intravascular | N | N | N | N | N | N | N | N | N | N: 5 |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N: 5 |
| Laparoscopic | N | N | N | N | N | N | N | N | N | N: 5 |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N: 5 |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | N | N: 5 |
| Other (Urological) | N | N | N | N | N | N | N | N | N | N: 5 |
| 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 (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | 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 | P: 5 |
| Small Organs [1] | | | | | | | | | | |
| 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 | 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 | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic 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 | P: 5 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | P | | P | P | P | | P | P: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | P | | P | P | P | | P | P: 5 |
| Musculo-skeletal Superficial [3] | | | P | | P | P | P | | P | P: 5 |
| Other (Urological) | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic 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) | | | | | | | | | | |
| N: New indication; P: Previously cleared by FDA; E:Added under Appendix E | | | | | | | | | | |
| | | | | | | Mode of Operations | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | 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] Neonatal Cephalic | E | E | E | | E | E | E | | E | E: 5 |
| 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) | | | | | | | | | | |
| SL3235 Intended use: Diagnostic ult | | | | | | asound imaging or fluid flow analysis of human body as follows: Mode of Operations Mode of Operation: | | | | |
| inical Applicatio | ਸ | N | PWD | CWD | Color Doppler | mplitude Doppler (PD) | Combined<br>す | Color Velocity apping (TVM | Harmonic maging (TE | Other (speci |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdomina | | | | | | | | | | |
| traoperative (Abdomina | | | | | | | | | | |
| traoperative Neurologic | | | | | | | | | | |
| Pediatric | d | d | d | | d | d | d | | d | S<br>். |
| Small Organs | d | d | d | | d | d | d | | d | സ<br>. d |
| eonatal Cephali | | | | | | | | | | |
| dult Cephalic | | | | | | | | | | |
| Cardiac [2 | | | | | | | | | | |
| ansesophageal (Cardia | | | | | | | | | | |
| ansesophageal (Non Cardiac) | | | | | | | | | | |
| ransrecta | | | | | | | | | | |
| ransvagina | | | | | | | | | | |
| ransurethra | | | | | | | | | | |
| ntravascular | | | | | | | | | | |
| eripheral Vascula | d | d | d | | d | d | d | | d | ഗ<br>id |
| aparoscopi | | | | | | | | | | |
| lusculo-skeletal Conventional<br>ಲು | d | d | d | | d | d | d | | d | ഹ<br>். |
| [3]<br>lusculo-skeletal Superficial | d | d | d | | d | d | d | | d | സ<br>d |
| ner (Urologica | | | | | | | | | | |

gnostic ultrasound imaging or fluid flow analysis of human body Dia Intended i 7410

under Append by FDA; E:Ad P: Previously : N

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD

1) Small organs includes Breast, Thyroid and etc.
2) Cardiac is Adult and Pediatric

1. Cardiac is Aquin and I volume
2. Musculo skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFL

[5] Compound Imaging (Mview)

[6] 3D/4D

To be cleared with this submission

{4}------------------------------------------------

ound imaging or fluid flow analysis of human body as follo . Di SP2730
Intended use

N: New indication; P: Previously cleared by FDA; E:Added under Appendix

[1]. Small Organs includes Breast, Thyroid and etc.

1) Other Organs includes Disease, Injury, etc.
2) Cardiac is Adult and Pediatric

1. Cardiac is **Not** and **Involuntary**
2. Muscle is **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+CW+CFM+PD

[5] Compound Imaging (Mview

reviously cleared via k14148

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDR

Page 3 of 18

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scription Use Only Per 21 CFR 801 Part D Concurrence of CDR

Only be part of creation
ER 801210

AL2442
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

[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

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview

reviously cleared via k14148

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Page 48 of 1535

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRR

[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 k14148

SL 1543
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Page 5 of 18

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Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

tion; 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.

[32 Musculo Skeletal - Nerve Block](url)

(4) Combined modes are: B+M; B+M+PW; CF

[5] Compound Imaging (Mview)

Under 510K submission
K142008

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 6 of 18

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Page 7 of 18

: Description of contents of 21 CFR Part 801 Prescription Device Labeling

scription Use Only Per 21 CFR 801 Part D Concurrence of CDR

[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

21. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview

reviously cleared via k14148

{9}------------------------------------------------

Prescription: Use only for clinical research. 21 CFR part 801.421. CAUTION: New Drug - Limited by Federal (or United States) law to investigational use.

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Neonatal Cephalic
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Clinical Application

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SL3323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

P: 5

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Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast, Thyroid and Testic
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

USD Small Organs Includes Breast, Thyroid

2) Cardiac ICU and Pediatric
3) Lung Specialists 1 New Block

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Combined moden ore: RMBW+CEM

Compound Imaging (Mvi

eviously cleared via k1414

# cription Use Only Per 21 CFR 801 Part D Concurrence of CD

Page 8 of 18

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scription Use Only Per 21 CFR 801 Part D Concurrence of CDF

| | d | d | | |
|---|---|---|-------------------------------------|---------------------------------------|
| | d | d | | |
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| | | | | |
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| œ | d | d | ed by FDA; E:Added under Appendix E | 1 ----------------------------------- |
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[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

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview

reviously cleared via k14148

| SL3332<br>Intended 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] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5 |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5 |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5 |
| Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5 |
| 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 | P: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | P | P | P: 5 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5 |

{11}------------------------------------------------

AC2541

| ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | |
|-------------------------------------------------------------------------------------------|----------|----------|------------|------------|----------------------|-------------------------------|---------------------|-------------------------------------|-------------------------------|------------------------|
| <b>Mode of Operations</b> | | | | | | | | | | |
| <b>Clinical Application</b> | <b>B</b> | <b>M</b> | <b>PWD</b> | <b>CWD</b> | <b>Color Doppler</b> | <b>Amplitude Doppler (PD)</b> | <b>Combined [4]</b> | <b>Color Velocity Mapping (TVM)</b> | <b>Harmonic Imaging (TEI)</b> | <b>Other (specify)</b> |
| 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 | | | | | | | | | | |
| 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 |

AC2541
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 E

[ I ] 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

20. Cardiac in Adult and Pediatric

3) Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview)

Previously cleared via k141486

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 10 of 18

{12}------------------------------------------------

- Prescription only. Do not use prior to consultation with your DRH care team.
- 21 CFR Part 801.109 - Caution: Federal law restricts this device to sale by or on the order of a physician.

| M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) |
|---|-----|-----|---------------|------------------------|--------------|------------------------------|
| | P | | P | P | P | |
| | | | P | P | P | |
| | | | P | P | P | |
| | P | | P | P | P | |
| | P | | P | P | | |
| | P | | P | P | | |

P

Transesophageal (Cardiac)
Transesophageal (Non Cardiac

Cardiac [2]

Other (specify

Harmonic
Imaging (TEI)

Color Velocity
Mapping (TVM)

в

Clinical Application

Ophthalmic

bdominal

Fetal

SC3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

P: 5

b

P: 5

ь

P

ntraoperative Neurological ntraoperative (Abdominal)

Pediatric

Small Organs [1]
Neonatal Cephalic dult Cephalic

d

P: 5

P

P: 5

P

P

Peripheral Vascular

aparoscopic

ransurethral

ransrectal

ntravascular ransvaginal

Musculo-skeletal Conventional Musculo-skeletal Superficial

3]

Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix 2

[1] Small Organs includes Breast, Thyroid and Testic
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

TO Small Organs Includes Breast, Thyroid, Adrenals, Pituitary, Ovaries, Testicles, Thymus, and Pancreas

TO Adults, Adults and Pediatrics, Pediatrics

1) Cardiac is Atrial and Ventricular
2) Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

Compound Imaging (Mvie

eviously cleared via k1414

scription Use Only Per 21 CFR 801 Part D Concurrence of CDF

Page 11 of 18

{13}------------------------------------------------

Page 12 of 18

Description of current Part 801 Prescription Drug Compounding Requirements under 21 CFR Only for Use in Conference Discussion

scription Use Only Per 21 CFR 801 Part D Concurrence of CDR

| Mode of Operations | | | | | | | | | | |
|----------------------------------|----|---|-----|-----|---------------|------------------------|--------------|------------------------------|------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | P | P | P | | P | P | P | | P | |
| 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: 5 |
| Laparoscopic | | | | | P | | | P | | |
| Musculo-skeletal Conventional | | | P | P | | P | P | | P | P: 5 |
| Musculo-skeletal Superficial [3] | | | P | P | | P | P | | P | P: 5 |
| Other (Urological) | PP | P | P | | P | P | P | | P | P: 5 |

SC3421
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

[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

[4] Combined modes are: B+M+PW+CFM+F

[5] Compound Imaging (Mview

reviously cleared via k141486

{14}------------------------------------------------

S2MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

| 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) |
|-----------------------------------------…