Predicate Devices

K111302, K100931, K081794, K091009, K110688

Reference Devices

K111302, K100931, K081794, K091009, K110688

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and features, including image processing techniques like Tissue Enhancement Imaging (TEI), XView, Multi View (MView), and Panoramic View (VPan). While these involve complex algorithms, there is no mention of AI, ML, or related terms like deep learning or neural networks. The description focuses on hardware features, imaging modes, and basic image manipulation/composition.

Therapeutic

No
The provided text specifies that the device "is a mainframe ultrasound system diagnostic general ultrasound studies," indicating its use for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "diagnostic general ultrasound studies."

SaMD (Software as a Medical Device)

No

The device description clearly details hardware components like a mainframe system with wheels, a portable system with a handle, LCD color displays, control panels, keyboards, and the ability to drive various probes. While there are software upgrades mentioned, the core device is a physical ultrasound system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed outside of the body (in vitro).
Device Function: The description clearly states that the Esaote Model 6400 and 7400 are ultrasound systems. Ultrasound systems use sound waves to create images of internal body structures. This is an in vivo (within the living body) imaging technique, not an in vitro test on samples.
Intended Use: The intended use describes diagnostic general ultrasound studies across various anatomical sites. This involves imaging the body directly, not analyzing biological samples.

Therefore, the function and intended use of these devices align with diagnostic imaging equipment, not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Esaote's Model 6400 is a mainframe ultrasound system 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 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 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.

Product codes

90IYN, 90IYO, 90ITX

Device Description

Model 6400 is a mainframe system equipped with wheels allowing them to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array and Doppler probes. 6400 control panel is equipped with a pull-out qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 was designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302.

6400 and 7400 Upgrade, defined herein, combine the cleared features of both 6400 and 7400 systems with other new software capabilities, listed below:

1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition.
1. Management of 3D/4D mode of operation.
1. Management of the acquisition of consecutive ultrasound images on extended surface. The final image is composed of the consecutive frames placed side (Panoramic View or VPan).

The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs (Breast, Thyroid, Testicles), Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Urologic.

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No clinical tests were performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K111302, K100931, K081794, K091009, K110688

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

0

K12231

NOV 2 7 2013

Traditional 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.

807.92(a)(1)

Submitter Information

Esaote S.p.A. Via di Caciolle 15 Firenze, Italy 50127

Contact Person:

Allison Scott 317.569.9500 x106 ascott@ansongroup.com

Date:

June 24, 2013

807.92(a)(2)

Devices

Common Name:	Ultrasound Imaging System
Trade Name:	6400 Ultrasound System
7400 Ultrasound System
Classification Name(s):	Ultrasound Pulse Doppler Imaging System 892.1550
Ultrasound Pulse Echo Imaging System 892.1560
Transducer, Ultrasonic, Diagnostic 892.1570
Classification Number:	90IYN, 90IYO, 90ITX

807.92(a)(3)

Device	Owner	510(k)
6400	Esaote	K111302
7400
7340	Esaote	K081794, K091009
and K110688
6200	Esaote	K100931

Predicate Device(s)

1

807.92(a)(4)

Device Description

Model 6400 is a mainframe system equipped with wheels allowing them to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array and Doppler probes. 6400 control panel is equipped with a pull-out gwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 was designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302.

6400 and 7400 Upgrade, defined herein, combine the cleared features of both 6400 and 7400 systems with other new software capabilities, listed below:

1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition.
1. Management of 3D/4D mode of operation.
1. Management of the acquisition of consecutive ultrasound images on extended surface. The final image is composed of the consecutive frames placed side (Panoramic View or VPan).

The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use

Esaote's Model 6400 is a mainframe ultrasound system 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 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 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.

2

807.92(a){6)

Technological Characteristics

・・ [] "

The 6400 and 7400 Upgrades employ the same fundamental technological characteristics as their predicated devices. The 6400 Upgrade model is substantially equivalent to Esaote 6200 model cleared by FDA via K100931 and to Esaote 6400 model cleared by FDA via K111302. The 7400 Upgrade model is substantially equivalent to Esacte 7340 model cleared by FDA via K081794. K091009 and K110688 and to Esaote 7400 model cleared by FDA via K111302.

· Clinical uses for which Esaote 6400 and 7400 models, cleared by FDA via K111302, are designed are not changed by 6400 and 7400 Upgrades, to be cleared via this submission.
· Clinical uses for which Esaote 6400 and 7400 Upgrades are designed are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote 7340 model, cleared via K081794. K091009 and K110688.
Both 6400 and 7400 Upgrades for managing Bi-Scan probes are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote 7340 model, cleared via K081794, K091009 and K110688.
· Both 6400 and 7400 Upgrades for managing 3D/4D mode of operation are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote 7340 model, cleared via K081794, K091009 and K110688.
Both 6400 and 7400 Upgrades for managing acquisition of consecutive ultrasound images on extended surface are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote 7340 model, cleared via K081794, K091009 and K110688.
· Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400, 6200 and 7340 are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400, 6200 and 7340 ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.

807.92(b)(1)

Summary of Non-Clinical Tests

The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.

IEC 60601-1 .
. IEC 60601-1-2
1EC 6060 1-2-37 .
. NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Qutput Indices on Diagnostic Ultrasound Equipment
. NEMA UD-2 - Acoustic Output Measurement Standard for Diagnostic Ultrasound

3

807.92(b)(2)

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusion

The 6400 and 7400 Upgrades are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 27, 2013

Esaote, S.p.A. % Ms. Allison Scott, Senior Consultant Anson Group 9001 Weslevan Road. Suite 200 INDIANAPOLIS IN 46268

Re: K132231

Trade/Device Name: 6400 Ultrasound System/MyLabSeven and 7400 Ultrasound System/MyLabAlpha Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 11, 2013 Received: November 13, 2013

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 MyLabSeven or MyLabAlpha, as described in your premarket notification:

Transducer Model Number

SP2430	S5MCW
SP2442	SHFCW
LA435	EC1123
LA523	SE3123
AL2442	TRT33
AL2443	ST2612
AL2445	BC441
SL1543	BC431
AC2541	BE1123
S2MCW	SB2C41

5

Page 2-Ms. Scott

..............................................................................................................................................................................

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/Medical Devices/Resourcesfor You/Industry/default.htm. 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industrv/default.htm.

Sincerely yours.

Smh.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

6

Indications for Use

K132231 510(k) Number (if known):

Device Name:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6400 and 7400 Ultrasound Systems

Indications for Use:

Esacte's Model 6400 is a mainframe ultrasound system 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 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.

Esacte'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, 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.

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 IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Smh.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K132231 510(k)

Page I of 23

7

6400

:

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(PDI) | Combined
(4) | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) |
|--------------------------------------|---|---|-----|-----|------------------|-------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P | P. S. N. 6 |
| Abdominal | P | P | P | P | P | P | P | | P | P. S. N. 6 |
| 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 | 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 | y | P (7) | P. 5 |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | | P | P. 5 |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | | P | P. S. N. 6 |
| Transvaginal | P | P | P | | P | P | P | | P | P. S. N. 6 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P. 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional
(3) | P | P | P | | P | P | P | | P | P. 5 |
| Musculo-skeletal Superficial 3 | P | P | P | | P | P | P | | P | P. 5 |
| Other (Urological) | P | P | P | P | P | P | P | | P | P. 5 |

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

| | Small Organs includes Breast, Thyroid and Teaticles

|2| Cardiac is Adult and Pediatric

|3| Musculo Skeletal - Nerve Block

What is the difference between a
Molecule, Atom, and Element?

|-1| Combined modes are: B+M+PW+CW+CFM+PD

|5| Compound imaging (Mview)

16| 3D/4D

|7) Includes contrast (CnTi) in Adult Cardisc for left ventruite operiforation and visualization of the left ventricular endocardial border

Previously cleared via k 1 | 1 | 302

Proscription Uso Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Haalth (CDRH)

.

8

7400

-- ".

| 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, N: 6 |
| Abdominal | P | P | P | P | P | P | P | | P | P. 5, N: 6 |
| 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 | 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) | P | P | P | P | P | P | P | P | P | P. 5 |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | | P | P. 5 |
| Transvaginal | P | P | P | | P | P | P | | P | P. 5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P. 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P. 5 |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P. 5 |
| Other (Urological) | P | P | P | | P | P | P | | P | P. 5 |

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

| | | Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

|3| Musculo Skeleta| - Nerve Block

|4| Combined modes are: B.M.PW.CW.CFM+PD

|5] Compound Imaging |Mview|

|6| 3D/4D

..

|7| Includes contrast (CnTI) in Adult Cardiac for left ventricte opscification and

Previously cleared vin k l 1 | 302

9

SP2430 (6400 and 7400 systems)

	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.S
Abdominal	P	P	P	P	P	P	P		P	P.S
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P.S
Small Organs [1]
Neonatal Cephalic	P	P	P	P	P	P	P		P	P.S
Adult Cephalic	P	P	P	P	P	P	P		P	P.S
Cardiac [2]	P	P	P	P	P	P	P	P	P(7)	P.S
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P		P	P		P	P.S
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

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

| 1] Small Organs includes Breakt, Thyroid and Tealicles

|2| Cardiac is Adult and Pediatric

, 13) Musculo Skeletal - Nerve Block

|4| Combined modes are: B+M+PW+CW+CFM+PD

|5| Campaund Imaging (Mview)

lel 3D/4D

|7| Includes contrast (CnTl) in Adult Cardusc for Jeft ventnele operification and visualization of the left ventricular endocardial border

Previously cleared via kl 1 1302

10

SP2442 (6400 and 7400 systems)

| | ---
Modo of Operations | | | | | | | | | | |
|-------------------------------------------------------------------------------------|---------------------------|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|--|
| Clintes Application | B | M | PWD | CWD | Color
Dappler | Amplitude
Doppler
IPDI | Combined
14) | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other {specify) | |
| Ophthalmic | | | | | | | | | | | |
| Felal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Untraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neumlogica? | | | | | | | | | | | |
| Pediatric | N | મ | N | મ | N | N | N | N | N | N 5 | |
| Small Organs | | | | | | | | | | | |
| Neonatal Cephalic | N | ਮ | N | N | ਮ | 14 | N | N | N | મ - ક | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | N | મ | N | મ | મ | મ | મ | N | H | મ ક | |
| Transcsophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intrasscular | | | | | | | | | | | |
| Pengheral Vascular | N | મ | N | N | N | N | N | N | N | N 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional
ti | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
| No New in disables of the county of the support of the program of the production of | | | | | | | | | | | |

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

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

[1] Small Organs includes Breast, Thyroid and Testicles

|2| Cardiac is Adult and Pediatric

|3] Musculo Skeletal - Nerve Block

|4] Combined modes are: B+M+PW+CW+CFM+PD

|5] Compound Imaging (Mview)

|6| 3D/4D

|7| includes contrast {CnTI) in Adult Cardiac for left ventrale opacification and

.

To be cleared through this aubmission

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

.

・

.

11

LA435 (6400 system)

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(PDI) | Combined
(4) | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) | |
|-----------------------------------|---|---|-----|-----|------------------|-------------------------------|-----------------|---------------------------------|---------------------------|-----------------|------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | | P. S |
| Small Organs [1] | P | P | P | | P | P | P | | P | | P S |
| 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. S |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | | P S |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | | P S |
| Other (Urological) | | | | | | | | | | | |

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

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

| | Small Organs includes Breast, Thyroid and Tealeries

|2| Cardiac is Adult and Pedialric

|J| Musculo Skeletal - Nerve Block

H} Combined modes are: B+M+PW+CFM+PD

|5| Compound Imaging |Mview|

|6| 3D/4D

|7| Includes contrast (CnTi) in Adult Cardiae for left ventricte opecification and

・

Previously cleared via k1 10688

12

LA523 (6400 system)

| 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 S |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | E | | E | E S |
| Small Organs [1] | P | P | P | | P | P | P | | P | P S |
| 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 S |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional
[3] | P | P | P | | P | P | P | | P | P S |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P S |
| Other (Urological) | | | | | | | | | | |

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

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

| | 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)

പ്ര 3D/4D

|7| Includes contrast (CnTi) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via k 1 1 1 302

13

AL2442 (6400 and 7400 systems)

.".

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

Clinical Application				Mode of Operations
	8	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
데	Color Velociry
Mapping (TVM)	Harmonic
maging (TEC)	Other {specify!
Ophthalmic
Fetal	ਦੇ	D	. E		દર	13	8	r	8:5
Abdaminal	P	P	P		P	P	P	P	8.5
Intraoperative (Abdominal)
Untraoperative Neurological
Pedialine	в	L	்		14	E	E	t	દ ર
Small Organs {{}	P	P	8		P	P	P	P	P 5
Neonatal Cephalic
Adult Cephalic
Cardiar 2)	P	P	P		P	P	P	P	8 5
Transesophageal (Cardiac)
Transcaophageal (Non Cardiac) .
Transrecial
Transvaginal
Transurethral
Intravascular
Penpherni Vascular	P	P	P		P	P	ﺎ ﺍﻟﻤ	P	P. S
Laparoscopic
Musculo-skeictal Conventional
િયા	P	P	P		P	P	P	P	6.8
Museulo-skeletal Superficial 3}	P	P	P		r	P	P	P	P. S
Other (Urological)

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

| ! | Small Organs includes Breast, Thyroid and Testicles

|2| Cardia: is Adult and Pediatinc

|3} Musculo Skeletal - Nerve Block

|4| Combined modes are: B+M+PW+CFM+PD

|5| Compound Imaging (Mview)

{6} 3D/4D

(7) Includes contrast (CnTi) in Adult Cardiac for left ventrice operification and
visualization of the left ventneular endocardial border

Previounly cleared via K111302

14

AL2443 (6400 and 7400 systems)

Intended 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
(PDI)	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
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)

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

(1) Small Organs includes Breast, Thyroid and Testicles

12} Cardiac is Adult and Pediatric

|3] Musculo Skeletal - Nerve Block

|4| Combined modes are: B+M+PW+CFM+PD

[5] Compound Imaging (Mview)

|6) 3D/4D

|7| Includes contrast (CnTi) in Adult Cardiac for left ventracle opacification and
visualization of the left ventricular endocardial border

Previously cleared via k ! ! ! ! 302

15

AL2445 (6400 and 7400 systems)

、

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

| Clinical Annikation | B | M | PWD | CWD | Color Doppler
(CFM) | Amplitude
Doppler
(PWD) | Combined [3] | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other
(specify) |
|-----------------------------------|---|---|-----|-----|------------------------|-------------------------------|--------------|---------------------------------|---------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | | N | N S |
| Small Organ [1] | N | N | N | | N | N | N | | N | N S |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac (2) | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | | N | N: S |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [2] | N | N | N | | N | N | N | | N | N: S |
| Musculo-skeletal Superficial [2] | N | N | N | | N | N | N | | N | N: S |
| Other (Urological) | | | | | | | | | | |

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

[ I | Small Organa includes Breast, Thyroid and Tealicles

| 2| Cardiac is Adult and Pediano

|3] Musculo Skeletal · Nerve Block

|4] Combined modes are: B+M+PW+CFM+PD

[5] Compound Imaging (Mview) [6] 3D/4D

{7| Includes contrass (CaTI) in Adult Cardine for left ventracle operification and

To be cleared through this
submission

16

SL1543 (6400 and 7400 systems)

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
(CFM)	Amplitude
Doppler
(PWD)	Combined [3]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other
(specify)
Ophthalmic
Fetal
Abdominal	N	N	N		N	N	N	N	N: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N		N	N	N	N	N: 5
Small Organ [1]	N	N	N		N	N	N	N	N: 5
Neonatal Cephalic
Adult Cephalic
Cardiac (2)	N	N	N		N	N	N	N
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N		N	N	N	N	N: 5
Laparoscopic
Musculo-skeletal Conventional [2]	N	N	N		N	N	N	N	N: 5
Musculo-skeletal Superficial [2]	N	N	N		N	N	N	N	N: 5
Other (Urological)

N: New Indication; P. Previosuly cleared by FDA; E:Added under Appendix E

| I | Small Organs includes Breast, Thyroid and Teaticles

|2| Cardiac is Adult and Pediatric

|3| Musculo Skeleta! · Nerve Block

[4] Combined modes are: B•M•PW•CPM•PD

|5} Compound Imaging (Mview) ിപ്പ് 3D/4D

|7| Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and

To be cleared through this submission

Prescription Use Only Per 21 CFR 801 Part D

17

	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. S
Abdominal	P	P	P		P	P	P	P	P. S
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. S
Laparoscopic
Musculo-skeletal Conventional
[3]	P	P	P		P	P	P	P	P. S
Musculo-skeletal Superficial [3]	P	P	P		P	P	P	P	P. S
Other (Urological)	P	P	P		P	P	P	P	P. S

AC2541 (6400 and 7400 systems)
Intended use. Diagnostic utrasound imaging or fluid flow enabysis of human body as follows:

[I] Small Organs includes Breast, Thyroid and Testiclea

[2] Cardiac is Adult and Pedialric

|3| Muscuio Skeletal • Nerve Block

[4] Combined mades are: B+M+PW+CPM+PD

[5] Compound Imaging (Mview)

|6) 3D/4D

includes contrast (CnTi) in Adult Cardiac for left ventricie opecification and
visualization of the left ventricular endocardial border

Previously cleared via k1111302

18

S2MCW (6400 and 7400 systems)

..

Intended 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	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs 1
Neonatal Cephalic
Adult Cephalic
Cardiac 2				P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional
3
Musculo-skeletal Superficial 3
Other (Urological)

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

| 1 | Small Organs includes Breast, Thyroid and Testicles

|2] Cardiac is Adult and Pedialric

|J| Musculo Skeletal - Nerve Black

|4| Combined modes are:

|5| Compound Imaging |Mviews

16| 3D/4D

[7] lociudes contrast (CnTT) in Adult Cardiac for left ventricle opecification and visualization of the left ventneular endocardial border

:

Previously cleared via k ! 1 1302

19

S5MCW (6400 and 7400 systems) Intended use: Disgnostic ultrasound imaging or fluid flow analysis of human body as follows:

· , ·

Clinical Application	Mode of Operations
	R	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
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

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

[1] Small Organs includes Breast, Thyroid and Tealicles

|2| Cardiac is Adult and Pediainc

|3| Musculo Skeletal · Nerve Block

|4] Combined modes are:

|5] Compound Imaging (Mview)

[6] 3D/4D

|7| Includes contrast (CnTi) in Adult Cardiac for left ventnele opecification and visualization of the left ventricular endocardial border

Previously cleared via k I I 1302

Prescription Use Only Per 21 CFR 801 Part D

Concurrence of Center for Devices and Radiological Health (CDRH)

20

SHFCW (6400 and 7400 systems)
Intended 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]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

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 Pediaine

|3} Musculo Skelctal - Nerve Block

|4| Combined modes are:

|5| Compound Imaging (Mview)

|b| 31}/ 41)

،

|7| Includes contrast (CnTi) in Adult Cardiar for left ventralie operification and visualization of the left ventricular endocardial border

Previously cleared via k | | | 302

21

Clinical Application	Mode of Operations
B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PDI)	Combined
[4]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P	P 5
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P	P	P. 5
Transvaginal	P	P	P		P	P	P	P	P 5
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

EC1123 (6400 s ystern)
Intended use: Diagnostic ultresound imaging or fluid flow analysis of human body as follows:

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

| } | Small Organs includes Breast, Thyrold and Teaticlea

|2| Cardiac is Adult and Pediatinc

|3| Musculo Skeletal - Nerve Block

|4} Combined modes ure: B+M+PW+CFM+PD

|5| Campound Imaging (Mview)

l6| 3D/4D

|7| Includes contrast (CnTi) in Adult Cardiac for left ventricle opacification and

Previously cleared via K110688

Prescription Use Only Per 21 CFR 801 Part D

22

SE3123 (6400 and 7400 systems)

Clinical Application		Mode of Operations
	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. S
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P	P	P. S
Transvaginal	P	P	P		P	P	P	P	P. 5
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P	P	P. S

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

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

[ ] | Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

|3| Musculo Skeletal - Nerce Black

|4| Cambuned modes are: B+M+PW+CFM+PD

{5} Compound Imaging {Mvsew|

16| 3D/4D

|7| Includes contrast (CaTI) in Adult Cardiac for left ventracte opacification and visualization of the left ventricular endocardial border

.

Previously cleared via k 1 1 1302

23

TRT33 (6400 system)

	Mode of Operations
Clinical Application	B	M	P/W	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
Small Organs 1
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P	P	P. S
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
3
Musculo-skeletal Superficial 3
Other (Urological)	P	P	P		P	P	P	P	P. S

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

| | 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)

le| JD/4D

|7} Includes contrast (CaTI) in Adult Cardiar for left ventry)e operification and visualization of the left ventricular endocardial border

Previously cleared via k1 | 1302

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

Page 18 of 23

24

ST2612 (6400 and 7400 systems)

.

	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
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	P 5
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

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

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

| | Small Organs includes Breast, Thyroid and Testicles

|2| Cardiac is Adult and Pedialric

]3] Musculo Skeletaj • Nerve Block

|4} Combined modes are: B+M+PW+CW+CFM+PD

|5| Compound Imaging (Mview)

16| 3D/4D

|7| Includes contrast (CnTI) in Adult Cardiae for left ventricie opacification and visualization of the fell ventricular endocardial horder

Previously cleared via k1111302

25

BC441 (6400 system)

	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	N	N	N		N	N	N	N	N: 5, 6
Abdominal	N	N	N		N	N	N	N	N: 5, 6
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

| 1 | Small Organs includes Breast, Thyroid and Testicles

|2] Cardiac in Adult and Pediatric |3} Musculo Skeletal - Nerve Block

|4} Combined modes are: B+M+PW+CFM+PD

H

(5) Compound Imaging (Mview)

מ/4D ₪/4D

{7} Includes contrast (Crill) in Adult Cardiac for left ventricte opecification and

.

To be cleared via this u braussion

26

BC431 (6400 system)

Clinical Application	Mode of Operations
	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, 6
Abdominal	P	P	P	P	P	P	P	P	P. 5, 6
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

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

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

[1] Small Organs includes Breast, Thyroid and Testicles

Cardian is Adult and Pedistric

|3| Musculo Skeleta] - Nerve Block

|4) Combined modes are: B+M+PW+CFM+PD

(5) Compound Imaging (Mview)

l6} 3D/4D

[7] Includes contrast (CnTD in Adult Cardine for left ventnele opacification and

Previously cleared via k I 10688

27

BE1123 (6400 system)

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	P. 5, 6
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P	P	P	P	P	P. 5, 6
Transvaginal	P	P	P	P	P	P	P	P. 5, 6
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

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

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

| | | Small Organs includes Breast, Thyroid and Teaticles

12| Cardiac is Adult and Pediatric

|3| Musculo Skeleiai • Nerve Black

|4| Combined modes are: B+M+PW+CFM+PD

|5) Compound Imaging (Mview)

|6| 3D/41>

|7) Includes contrast (CnTl) in Adult Cardine for left ventricle opecification and

Previously cleared via k | 10688

28

SB2C41 (6400 and 7400 systems)

Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	N	N	N	N	N	N	N	N	N 5, 6
Abdominal	N	N	N	N	N	N	N	N	N 5, 6
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

{ | | Small Organs includes Breast, Thyroud and Testicles

12| Cardiac is Adult and Pediatric

|3| Musculo Skeleta! - Nerve Block

|-1) Combined modes are: B+M+PW+CFM+PD

(5) Compound Imaging |Mview|

16] JD/4D

|7| Includes contrast (CnT) in Adult Cardiac for left ventricle operification and

To be cleared via this submission

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CORH)

'