6250 ULTRASOUND SYTEMS

K103152 · Esaote, S.p.A. · IYN · Jan 7, 2011 · Radiology

Device Facts

• Record ID: K103152
• Device Name: 6250 ULTRASOUND SYTEMS
• Applicant: Esaote, S.p.A.
• Product Code: IYN · Radiology
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic. Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 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. The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information. The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Device Story

Mainframe ultrasound system; performs diagnostic general ultrasound studies; inputs include ultrasound signals from linear, convex, and phased array probes; optional Virtual Navigator license integrates secondary modality images (CT/MR) for morphological assessment; system features B-Mode, Doppler, Color Flow, Tissue Velocity Mapping, and Tissue Enhancement Imaging; operated by clinicians in clinical settings; output displayed on LCD monitor; assists in biopsy guidance, needle placement, and peripheral nerve blocks; modifications include touch screen control panel, updated housing, and PCB layout; benefits include improved workflow and diagnostic confidence via multi-modality visualization.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design verification and validation of the modified user interface and firmware, confirming that the modifications do not impact the safety or effectiveness of the ultrasound imaging system.

Technological Characteristics

Mainframe ultrasound system; LCD color display; supports linear, convex, and phased array probes. Materials: plastic housing. Connectivity: supports optional Virtual Navigator (CT/MR integration). Software: firmware/software updated for touch screen interface. Quality standards: ISO 9001:2000 and ISO 13485 certified.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients undergoing cardiac, transesophageal, peripheral vascular, neonatal/adult cephalic, small organ (breast, thyroid, testicles), musculoskeletal, abdominal, fetal, transvaginal, transrectal, pediatric, intraoperative, laparoscopic, and urologic studies. Includes needle guidance for biopsy and nerve blocks. Contraindicated for use with cardiac pacemakers or life-supporting equipment when using the Virtual Navigator tracking system.

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

• 6150 (K051308)
• 6150 (K052805)
• 6150 (K060827)
• 6150 (K081386)
• 6150 (K091009)

Submission Summary (Full Text)

{0}------------------------------------------------

Esaote, S.p.A.

JAN - 7 2011

# K103152 Special 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).

807.92(a)(1)

# Submitter Information

Esaote S.p.A. Via Siffredi 58 Genoa, Italy 16153

Contact Person:

Allison Scott 317.569.9500 x106 [e-mail]

Date:

October 22, 2010

807.92(a)(2)

Trade Name: 6250 System

Common Name: Ultrasound Imaging System

Classification Name(s):

Classification Number: 90IYN; 90IYO; 90ITX

807.92(a)(3)

# Predicate Device(s)

Ultrasonic pulse Doppler imaging system 892.1550 Ultrasonic pulsed echo imaging system 892.1560

K051308, K052805, K060827, K081386 and K091009

6150

Esaote, S.p.A.

{1}------------------------------------------------

Esaote, S.p.A.

# 807.92 (a)(4)

# Device Description

The 6150 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes.

The 6150 system has been cleared by FDA via K051308, K052805, K060827, K081386 and K091009.

The modified 6150, with respect to the cleared version 6150 via K051308, K052805, K060827, K081386 and K091009, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

- a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
- b. New plastic housing of the system both to include the touch screen and to give a new style
- c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
- Software/Firmware modification to translate the touch screen information for the d. software: main software characteristics and performances have not been changed.

The 6250 is the model name of the modified 6150. The set of probes of the 6150 is exactly the same.

The 6250 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5) :

, -

## Intended Use(s)

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic. Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 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.

{2}------------------------------------------------

Special 510(k) Summary 6250 System Esaote, S.p.A.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.
------------------------------------------------------------------------------------------------------------------------------------------------------

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

# 807.92(a)(6)

# Technological Characteristics

The modifications reflected in this Special 510(k) for the 6250 are intended to improve the system's performance. The modifications have not altered the fundamental scientific technology or the intended use of the unmodified version of the 6150 cleared via K051308, K052805, K060827, K081386 and K091009.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Esaote S.p.A. % Ms. Allison Scott, RAC Regulatory Associate Anson Group 11460 N. Meridian Street, Suite 150 CARMEL IN 46032

JAN - 7 2011

Re: K103152 Trade/Device Name: 6250 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 22, 2010 Received: October 26, 2010

Dear Ms. Scott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the 6250 Ultrasound Systems, as described in your premarket notification:

| Transducer Model Number | | | |
|-------------------------|---------|---------|--------|
| PA230 | LA532 | CA631 | TEE022 |
| PA122 | LA932 | 2CW | TEE022 |
| PA023 | C5-2R13 | 5CW | IOE323 |
| PA240 | CA123 | HF CW | LP323 |
| LA332 | CA421 | EC123 | BC431 |
| LA435 | CA621 | EC1123. | BL433 |
| LA522 | CA430 | EC1123 | |
| LA523 | CA431 | BE1123 | |

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

{5}------------------------------------------------

Model 6250

JAN - 7 2011

# Indications for Use

510(k) Number (if known):

Device Name:

6250 Ultrasound Systems

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 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.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103152

{6}------------------------------------------------

| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | |
|----------------------------------------------------------------------------------------------|---|---|-----|-----|---------------|------------------------|--------------|------------------------------|------------------------|------------------------|
| 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 | P | 5,6,7,8, 12, 13 |
| Fetal | P | P | P | P | P | P | P | P | P | 5, 6, 7, 8, 12, 13 |
| Abdominal | P | P | P | P | P | P | P | P | P | 5, 6, 8, 12, 13 |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P | P | 5, 6, 7, 8, 12, 13 |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | 5, 6, 7, 8, 12, 13, 14 |
| Pediatric | P | P | P | P | P | P | P | P | P | 5, 6, 8, 12 |
| Small Organ [1] | P | P | P | P | P | P | P | P | P | 5, 6, 7, 8, 12 |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P(15) | 5,6,7,8, 10, 11, 12 |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | 5, 6, 8, 10, 11, 12 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | 5, 6, 7, 8, 12, 13, 14 |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | 5, 6, 7, 8, 12, 13 |
| Transesophageal (Non Cardiac) | P | P | P | P | P | P | P | P | P | 5, 6, 7, 8, 12, 13 |
| Transrectal | P | P | P | P | P | P | P | P | P | 5,6,7, 8, 12, 13, 14 |
| Transvaginal | P | P | P | P | P | P | P | P | P | 5, 6, 7, 8, 12, 13, 14 |
| Transurethral | P | P | P | P | P | P | P | P | P | 5.6, 7, 8, 12, 13 |
| Intravascular | P | P | P | P | P | P | P | P | P | 5.6, 7, 8, 12, 13 |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | 5.6, 7, 8, 12, 13 |
| Laparoscopic | P | P | P | P | P | P | P | P | P | 5.6, 7, 8, 12, 13 |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | 5.6, 7, 8, 12, 13 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | 5.6, 7, 8, 12, 13 |
| Other (Urological) | P | P | P | P | P | P | P | P | P | 5.6, 7, 8, 12, 13 |
| : New indication; P: Previously cleared by FDA: E:Added under Appendix E | | | | | | | | | | |

ાં મુખ્યત્વે મકામ ગ od imaging or 6250 (Modified 6150)
Intended use: Discostic ultrass

1.) Small Organs includes:

|1] Small Organs includes
Breast, Thyroid and Testicles

|2| Cardiac is Adult and Pediatric

|4| Combined modes are:
B+M+PW+CW+CPM+PD
|5| Compass M-Mode (CMM) |2| Cardiac is Adult and
Pediatric
|3| Musculo Skeletal - Nerve
Block

613D
14D

1714D
[18] Уран

|8| Урап
|9| Xview

[9] Xview:
[10] Stress

[0] Matrix
[10] Stress
[11] XStrain

[10] Stress
[11] Xstrain
[12] Compound Imaging

|13| Trapezoidal View (TP-View)
|14| Elastography

ा से ही स्थान

Previously cleared via k051308,
k052805, k060827, k081386
and k091009

Prescription Use Only Per 21 CFR 801 Part D Concurrence

(Division Sign-Off)
Division of Radiological Devices

YH35152
510K

{7}------------------------------------------------

| 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 | P | P | P | P | P | P | P | P | P | 5, 6, 9 |
| Fetal | P | P | P | P | P | P | P | P | P | 5, 6, 9 |
| Abdominal | P | P | P | P | P | P | P | P | P | 5, 6, 9 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | 5, 6, 9 |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | 5, 6, 9 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P(16) | 5, 6, 9, 10, 11 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | 5, 6, 9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

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

[1] Small Organs includes
Breast, Thyroid and Testicles

|2] Cardiac is Adult and Pediatri

|3) Musculo Skeletal • Nerv
Block

(Division of Faction Sign-Off)

K103152

510K-

(4| Combined modes are:
B+M+PW+CW+CW+CFM+PD
[5] Compass M-Mode (CMM)

Total XView
Total Stress

110| stress
111| X strain

(6) 3D
(9) XV (vew
(1) V Strees
(1) ) Harburg sontrast (GaTI) in Adult Cardiac for left ventricle opacification of
visualization of the left ventricular endocardial bord

Previously cleared via k10093

# PA230
Intended use: Dia

{8}------------------------------------------------

| 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 | 5,6,9 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | 5,6,9 |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | 5,6,9 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | P | P | P | P | P | P | | P | 5, 6, 9, 10, 11 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | 5,6,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

PA122
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

100

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiar is Adult and
Pediatric
[3] Musculo Skeletal - Nerve
Block

|4| Combined modes are:
|5| Combined M-Mode |CMM)
|5| Comment M-Mode |CMM |
|6| STD
|0| XViews
|11| XViews
|111| Xartrain

[5] Compress M-Mode | Color
(6) 3D

[9] XView
[110] Stress

\$\sigma*{11}\$ stress
\$\epsilon*{11}\$ Xstrain

Previously cleared via k10043

Prescription Use Only Per 21 CFR 801 Part D
concurrence of CDRH, Office of In Vitro Diagnostic

K16352
10K

# Sign-Off Radiological Devices
Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safety

510K
K103153

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

PA023

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

| 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 | | | | | P | P | P | | P | 5, 6, 9 |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P | 5, 6, 9 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | P | P | P | P | P | P | | P | 5, 6, 9, 10, 11 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | | P | P | P | | P | 5, 6, 9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
| N: New indication; P: Previously cleared by FDA; E:Added under Appendix E | | | | | | | | | | |

[1] Small Organs includes
Breast, Thyroid and Testicles

i ediatrit
|3| Musculo Skeletal - Nerve
Block |2| Cardiac is Adult and
Pediatric

|3| Module Block
|4| Combined modes are:

B+M+PW+CW+CFM+PD

151 Compass M-Mode ICM

lal Combined model are:
JSI Gembers M-Mode (CMM)
JST Gembers M-Mode (CMM)

Previously cleared via k100931

(Division Sign-Off)
Division of Radiological Device

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510K
Y163152

Prescription Use Only Per 21 CFFR 801 Part D
Concurrence of CDRH, Office of In Vitro

{10}------------------------------------------------

PA 240
Intended use: Diagnostic ultrasound imaging or fluíd flow analysis of human body as follows of Ollows

| 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<br>(specify) |
|-----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|--------------------|
| Ophthalmic | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Fetal | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Abdominal | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Intraoperative Neurological | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Pediatric | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Small Organ [1] | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Adult Cephalic | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Cardiac [2] | P | P | P | P | P | P | P | | P (16) | 5, 6, 9, 10, 11 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

patient

[1] Small Organs includes
Breast, Thyroid and Testicles

\$
\frac{1}{2}\$

(2) Cardiac is Adult and
Pediatsic

realinks
|3| Musculo Skeletal - Nerve
Block

|4] Combined modes are:
B+M+PW+CW+CFM+PD
|5] Compass M-Mode (CMM)

B+M+PW+CW+CFM+
[5] Compass M-Model
[6] 3D
[a] Yirivu

רו אינט אינטייליג וואס שיינוש שניי
1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1972

[16] Includes contrast (CuTI) in Adult Cardiac for left ventricle opacification and
visualization of the lett ventricular endocardial border

Previously cleared via k100931

(Division Sign-Off)

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510K
K163132

Prescription Use Only Per 21 CFFR 801 Part D
Concurrence of CDRH, Office of In Vitro

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

| 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 | | | |
| Abdominal | P | P | P | P | P | P | P | | P | 6, 8, 9, 12, 13 |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | 6, 8, 9, 12, 13 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | 6, 8, 9, 12, 13 |
| Small Organ [1] | P | P | P | P | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | 6, 8, 9, 12, 13 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | | P | 6,8, 9, 10, 12, 12, 13 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | 6, 8, 9, 12, 13 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Other (Urological) | P | P | P | P | P | P | P | | P | 6, 8, 9, 12, 13 |

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

|1| Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

(12) Compound Imaging (Mview)
(13) Trapezoidal View (TP-View )
(14) Elastography [3] Musculo Skeletal - Nerve [4] Combined modes are:
B+M+PW+CFM+PD | 1 | Strain |10] Stress |8] Vpan
|9| XView |6] 3D Block

Sign-Off Rediclosion Sign-Off
Division of Rediclorical Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

ਨਾਲ ਡਾ 22 2

510K-

Previously cleared via k100931

# LA332

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

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|---------------|------------------------|--------------|------------------------------|------------------------|---------------------|
| Ophthalmic | P | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | | 6, 8, 9, 12, 13 |
| Abdominal | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Small Organ [1] | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Other (Urological) | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |

L.A.435
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

| I ] Small Organs includes
Breast, Thyroid and Testicles

(6) Vpan
(8) Vpan
(9) X Componind Imaging (Mview)
(13) Trapezoidal View (TP-View (TP-View )
(14) Elrastography |3] Musculo Skeletal - Nerve
Block |4] Combined modes are:
B+M+PW+CFM+PJ) |2] Cardiac is Adult and
Pediatric

Previously cleared via k10093

(Division Sign-Off)

Sign-Off (Division Sign-Off)
Division of In Vitro Division Sign-Off)
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K
H163152

escription Use Only Per 21 CFFR 801 Part D
Concurrence of CDRH, Office of In Vitro

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

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Abdominal | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Small Organ [1] | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Adult Cephalic [2] | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Other (Urological) | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |

i ટ ultr nostic LA522
Intended use: Diag New indication; P; Previously cleared by FDA; E:Added under Append 2

|l | Small Organs includes
Breast, Thyroid and Testicles

|2] Cardiac is Adult and Pediati

|3) Musculo Skeletal - Nerv
Block [4] Combined modes are
[3+M+PW+CFM+]*D

|6) Vipan
|8| Vipan
|9| Viewspound Imaging |Mriew
|13| Timpeoind View [TP-View
|14| Trapeosidal View [TP-View
|14| Elastography

Previously cleared via k10093

ర പ്രശ്ചാട 510K-

(Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Salety

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

| Extended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | Mode of Operations | | | | | |
|----------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-------------------------|--|
| | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | | P | P | P | | | | |
| Retal | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 | |
| Abdominal | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | 6, 8, 9, 12, 13 | |
| Small Organ [1] | P | P | P | | P | P | P | P | P | 6, 8, 9, 12, 13, 14 | |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | 6, 8, 9, 10, 12, 12, 13 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | 6, 8, 9, 12, 13, 14 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | 6, 8, 9, 12, 13, 14 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | P | P | 6, 8, 9, 12, 13, 14 | |
| Other (Urological) | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 | |

or flu ostic ultrasound imaging oo: Dia LA523

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

[1] Small Organs includes
Breast, Thyroid and Trsticle

[2] Cardiac is Adult and
Pediatric
[3] Musculo Skeletal - Nerve
Block

[3] Brachial Plexus Nerve
Block
[4] Combined modes are:
P+M+PW/"C"+M+PD

[10] Stress
[11] Strain
[12] Compound Imaging (Mview)
[13] Trapezoidal View (TP-View)
|14| Elastography

Previously cleared via k10093

(Division Sign-Off)

(Division Sign-Off)

510K
7163153

Prescription Use Only Per 21 CFR 801 Parl D
oncurrence of CDRH, Office of In Vitro Diagnost

{15}------------------------------------------------

| 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 | 6, 8, 9, 12, 13 |
| Abdominal | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Small Organ [1] | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Other (Urological) | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |

LA532
Intended use: Diagnostic ultrasound imaging of fluid flow analysis of human body as follow

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

[1] Small Organs includes
Breast, Thyroid and Testicles

|3] Musculo Skeleta! - Nerve (4) Combined modes arc:
B+M+PW+CFM+PD [2] Cardiac is Adult and
Pediatric (6) 3D Block

[8] Vpan
[9] XView
[12] Compound Imaging (Mview)
[13] Trapezoidal View (TP-View J

Previously cleared via k091009

(Division Sign-Off)

(Division of Fadiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Eveluation and Safety

510K-
K103153

{16}------------------------------------------------

| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | |
|----------------------------------------------------------------------------------------------|--------------------|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| | Mode of Operations | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | P | P | P | | P | P | P | | | |
| Fetal | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Abdominal | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Small Organ [1] | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Other (Urological) | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| N: New indication; P: Previously cleared by FDA; E:Added under Appendix E | | | | | | | | | | |

ni LA923
Intended i

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiae is Adult and
Pediatric

[3] Musculo Skeletal - Nen
Block [4] Combined modes are:
B+M+PW+CFM+PD

5] 3D
8] Vpan
1] XYView

[6] Vpan
[8] Vpan
[9] XView
[12] Clompound Imaging (Mview [

reviously cleared via k10093

1

Sign-Off (Division Sign-Off)

R1035153
510K

scription Use Only Per 21 CFR 801 Part
Concurrence of CDRH, Office of In Vitro

{17}------------------------------------------------

| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | |
|----------------------------------------------------------------------------------------------|--------------------|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|------------------------|
| Clinical Application | Mode of Operations | | | | | | | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| | B | M | PWD | CWD | Color<br>Doppler | Amplitud…