AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)

K014168 · Biosound Esaote, Inc. · IYN · Apr 25, 2002 · Radiology

Device Facts

• Record ID: K014168
• Device Name: AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
• Applicant: Biosound Esaote, Inc.
• Product Code: IYN · Radiology
• Decision Date: Apr 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AU6 (Technos/TechnosMP) ultrasound imaging system is intended to be used by a physician for diagnostic imaging in pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic and musculoskeletal applications.

Device Story

The AU6 (Technos/TechnosMP) is an ultrasound imaging system used by physicians for diagnostic imaging across various clinical applications. It processes ultrasonic signals from connected transducers (linear, convex, phased, pencil) to generate images in modes including B-mode, M-mode, PW Doppler, CW Doppler, Color Flow Mapping (CFM), and Amplitude Doppler (PD). The system supports 3D imaging and Tissue Enhanced Imaging (TEI). It is used in clinical settings such as ORs and clinics. Output is displayed on an SVGA monitor for physician interpretation to support clinical decision-making. The device includes digital archival capabilities and biopsy attachment support.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Ultrasound imaging system utilizing linear, convex, phased, and pencil array transducers. Imaging modes: B, M, PW, CW, CFM, PD, and TEI. Connectivity: Digital archival, VCR/Printer support. Electrical safety: IEC 60601-1. Ultrasound safety: Track 3. Display: SVGA. Software: Embedded system for image processing and 3D reconstruction.

Indications for Use

Indicated for diagnostic ultrasound imaging in pediatric, small organ (thyroid, testicles, breast), neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, and musculoskeletal (conventional and superficial) applications. Includes vein mapping and sclerotherapy for peripheral vascular applications.

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

• AU6 (Technos/TechnosMP) (K990360)
• AU5 3D (K000931)

Submission Summary (Full Text)

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

K014168

### APR 2 5 2002

510(k) AU6 Technos/Technos MP Ultrasound Imaging System Biosound Esaote

# 510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 1807.92(a).

807.92(a)(1)

# Submitter Information

| Colleen Hittle Densmore, Official Correspondent<br>8000 Castleway Drive<br>Indianapolis, IN 46250<br>Phone:<br>Facsimile: | [phone]<br>[phone] | |
|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------|
| Contact Person: | Colleen Hittle Densmore | |
| Date: | December 11, 2001 | |
| 807.92(a)(2) | | |
| Trade Name: | AU6 (Technos/Technos MP) Ultrasound Imaging System<br>(Addition of 3D Imaging Mode and Musculoskeletal<br>Indication) | |
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulsed doppler imaging system | 892.1550 |
| Classification Number: | 90IYN<br>90IYO | |
| 807.92(a)(3) | Predicate Device(s) | |
| Esaote<br>Esaote | AU6 (Technos/TechnosMP)<br>AU5 3D | K990360<br>K000931 |

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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

510(k) AU6 (Technos/TechnosMP) Ultrasound Imaging System Biosound Esaote

#### 807.92(a)(5)

### Intended Use(s)

The AU6 (Technos/TechnosMP) ultrasound imaging system is intended to be used by a physician for diagnostic imaging in pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic and musculoskeletal applications.

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

#### 510(k) Summary

910(K) Summal 7
AU6 (Technos/TechnosMP) Ultrasound Imaging System Biosound Esaote

| General Characteristic | Esaote<br>AU5 3D<br>(K000931) | Esaote<br>AU6 Digital<br>(Technos)<br>(K990360) | Esaote<br>Technos/TechnosMP<br>This Submission<br>3D/Musculoskeletal |
|-------------------------------|-------------------------------|-------------------------------------------------|----------------------------------------------------------------------|
| Transducer Type | | | |
| Linear Array | YES | YES | YES |
| Convex Array | YES | YES | YES |
| Phased Array | NO | YES | YES |
| Pencil | NO | YES | YES |
| Imaging Modes of Operation | | | |
| A Mode | NO | NO | NO |
| B Mode | YES | YES | YES |
| M Mode | YES | YES | YES |
| PWD (PW) | YES | YES | YES |
| CWD | NO | YES | YES |
| (Color Doppler) CFM | YES | YES | YES |
| (Amplitude Doppler) PD | YES | YES | YES |
| Color Velocity Imaging | NO | NO | NO |
| Combined (B+PW+CFM+PD+M) | YES | YES | YES |
| Duplex | YES | YES | YES |
| Triplex | YES | YES | YES |
| TEI/CTEI | YES | YES | YES |
| Modules | | | |
| ECG | YES | YES | YES |
| Cardio | NO | YES | YES |
| 3D | YES | NO | YES |
| Clinical Applications | | | |
| Obstetric/Fetal | YES | YES | YES |
| Abdominal | YES | YES | YES |
| Intra-operative | YES | YES | YES |
| Pediatric | YES | YES | YES |
| Small Organ | YES | YES | YES |
| Neonatal Cephalic | YES | YES | YES |
| Adult Cephalic | YES | YES | YES |
| Cardiac | YES | YES | YES |
| Trans-esophageal | NO | YES | YES |
| Trans-rectal | YES | YES | YES |
| Trans-vaginal | YES | YES | YES |
| Peripheral Vascular | YES | YES | YES |
| Laparoscopic | YES | YES | YES |
| Muscolo-skeletal Conventional | NO | NO | YES |
| Muscolo-skeletal Superficial | NO | NO | YES |
| Urological | NO | YES | YES |
| Miscellaneous | | | |
| Biopsy attachments | YES | YES | YES |
| Display type | SVGA | SVGA | SVGA |
| VCR/Printer | YES | YES | YES |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| Ultrasound safety | Track 3 | Track 3 | Track 3 |
| Digital Archival | YES | YES | YES |

Comparison Chart for Substantial Equivalence

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol composed of three overlapping profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Colleen J. Densmore Official Correspondent The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

APR 2 5 2002

Re: K014168

Trade Name: AU6 (Technos/Technos MP) Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: March 28, 2002 Received: April 1, 2002

Dear Ms. Densmore:

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 Amerodments, 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 the Everal Cofin 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 AU6 (Technos/Technos MP) Ultrasound Imaging System, as described in your premarket notification:

#### Transducer Model Number

| IOE323 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| LA424 |
| LA522E |
| LA523 |
| CA123 |
| CA421<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| CA621 |

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| CAB411A |
|---------|
| EC123 |
| LP323 |
| TRT23 |
| PA220E |
| PA122E |

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 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); 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.

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 contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# Technos /Technos™ System

3D DSM2 & DSM3 / Musculoskeletal

Appendix F

| | Mode of Operation | | | | | | | | | |
|-----------------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| ·Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | P (3) |
| Fetal | | P | P | P | | P | P | | P (1) | N (2) |
| Abdominal | | P | P | P | P | P | P | | P (1) | P (3)<br>N (2) |
| Intraoperative Abdominal | | P | P | P | | P | P | | P (1) | P (3)<br>N (2) |
| Intraoperative Peripheral<br>vascular | | P | P | P | | P | P | | P (1) | P (3)<br>N (2) |
| Intraoperative Neurological | | | | | | | | | | E(3) |
| Pediatric | | E | E | E | E | E | E | | E (1) | N (2) |
| Small Organ (specify) | | P | P | P | | P | P | | P (1) | P (3)<br>N (2) |
| Neonatal Cephalic | | P | P | P | P | P | P | | P (1) | P (3)<br>N (2) |
| Adult Cephalic | | P | P | P | P | P | P | | P (1) | P (3)<br>N (2) |
| Cardiac | | P | P | P | P | P | P | | P (1) | P (3)<br>N (2) |
| Transesophageal | | P | P | P | | P | P | | P (1) | P (3)<br>N (2) |
| Transrectal | | P | P | P | | P | P | | P (1) | P (3)<br>N (2) |
| Transvaginal | | P | P | P | | P | P | | P (1) | P (3)<br>N (2) |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P (1) | P (3)<br>N (2) |
| Laparoscopic | | P | P | P | | P | P | | P (1) | P (3)<br>N (2) |
| Musculoskeletal Conventional | | N | N | N | | N | N | | N(1) | N(3) |
| Muscoloskeletal Superficial | | N | N | N | | N | N | | N(1) | N(2) |
| Other (Urological) | | P | P | P | | P | P | | P (1) | P (3)<br>N (2) |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Obstetric/Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | E | E | E | | E | E | | E (1) | N(2) |
| Intraoperative (Peripheral<br>vascular) | | E | E | E | | E | E | | E(1) | N(2) |
| Pediatric | | E | E | E | | E | E | | E (1) | N(2) |
| Small Organ (specify) | | E | E | E | | E | E | | E (1) | N(2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Inhtravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | | E (1) | N(2) |
| Laparoscopic | | | | | | | | | | |
| Muscoloskeletal Conventional | | N | N | N | | N | N | | N(1) | N(2) |
| Muscoloskeletal Superficial | | N | N | N | | N | N | | N(1) | N(2) |
| Other (specify) | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix 1

Additional Comments:

Small Organs (specifically, thyroid, testicles and breast);

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM,

M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live. MTCTM, BTT W, DTM, DTC, Inc. In the finere in single interest and in the PW+CFM+PD, where only one mode is live; Ochibinationer any other any othere all single modes are live.

Note (2): 3D-DSM2/DSM3

Note (3): TEI (Tissue Enhanced Imaging) mode (AU6 system was cleared for TEI via K000681)

**Prescription Use**
**(Per 21 CFR 801.109)**

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K014168

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

#### IOE323

#### 3D & Musculoskeletal

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Small Organs (specifically, thyroid, testicles and breast); Sinan Organis (specifican); in Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM, Collibinations: ally conformation of the rows where all single modes are live.

Note (2): 3D-DSM2

**Prescription Use**
(Per 21 CFR 801.109)

Nancy brozdon

(Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number

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

#### LA424 3D & Musculoskeletal

| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | E (1) | N(2) |
| Small Organ (specify) | | E | E | E | | E | E | | E (1) | N(2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic/Transcranic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Inhtravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | | E (1) | N(2) |
| Laparoscopic | | | | | | | | | | |
| Muscoloskeletal Conventional | | N | N | N | | N | N | | N (1) | N(2) |
| Muscoloskeletal Superficial | | N | N | N | | N | N | | N (1) | N(2) |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix F

Additional Comments: Additional Octiments:
Small Organs (specifically, thyroid, testicles and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM, Comonations: any ochiomatcher. FM+PW where all single modes are live.

Note (2): 3D-DSM2/DSM3

**Prescription Use**
(Per 21 CFR 801.109)

Nancy Hodgson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K014168

8

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

# LA522E

#### 3D & Musculoskeletal

| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | E (1) | N(2) |
| Small Organ (specify) | | E | E | E | | E | E | | E (1) | N(2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Inhtravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | | E(1) | N(2) |
| Laparoscopic | | | | | | | | | | |
| Muscoloskeletal Conventional | | N | N | N | | N | N | | N (1) | N(2) |
| Muscoloskeletal Superficial | | N | N | N | | N | N | | N (1) | N(2) |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix T

Additional Comments:

Small Organs (specifically, thyroid, testicles and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+C I M+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live

Note (2): 3D-DSM2/DSM3

**Prescription Use**
(Per 21 CFR 801.109)

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K014168

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

#### LA523 3D & Musculoskeletal

| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | E (1) | N(2) |
| Small Organ (specify) | | E | E | E | | E | E | | E (1) | N(2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Inhtravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | | E (1) | N(2) |
| Laparoscopic | | | | | | | | | | |
| Muscoloskeletal Conventional | | N | N | N | | N | N | | N (1) | N(2) |
| Muscoloskeletal Superficial | | N | N | N | | N | N | | N (1) | N(2) |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Small Organs (specifically, thyroid, testicles and breast);

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): 3D-D\$M/DSM3

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K014/68

ma

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

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | E | E | E | | E | E | | E (1) | N(2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | E (1) | N(2) |
| Small Organ (specify) | | E | E | E | | E | E | | E (1) | N(2) |
| Neonatal Cephalic | | E | E | E | | E | E | | E (1) | N(2) |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | | E (1) | N(2) |
| Laparoscopic | | | | | | | | | | |
| Muscoloskeletal<br>Conventional | | | | | | | | | | |
| Muscoloskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
| . | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophtalmic | | | | | | | | | | E(3) |
| Fetal | | E | E | E | | E | E | | E (1) | E(3)<br>N(2) |
| Abdominal | | E | E | E | | E | E | | E (1) | E(3)<br>N(2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | E (1) | E(3)<br>N(2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | E | E | E | | E | E | | E (1) | E(3)<br>N(2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | E(3)<br>N(2) |
| Peripheral Vascular | | E | E | E | | E | E | | E (1) | E(3)<br>N(2) |
| Laparoscopic | | | | | | | | | | |
| Muscoloskeletal<br>Conventional | | | | | | | | | | |
| Muscoloskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

Additional Comments:

Small Organs (specifically, thyroid, testicles and breast);

Peripheral Vascular to include Vein Mapping & Scleroterapy

Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; :Note (1): B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live. 3D-DSM2 (2):

2); 3D-USN

L Prescription Use _ (Per 21 CFR 801.109)

Nancy C Hogdon

---

(Division Sign-Off)

Division of Reproductive Abdominal and Radiological Devices 510(k) Number _

1 I

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

Additional Comments:

Additional Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; is Combinations: any combination of the rollowing modes. But in a modes are live.

Note (2): 3D-DSM2/DSM3

Note (Z). SD-DSM2DONG
Note (3): TEI (Tissue Enhanced Imaging) mode (AU6 system was cleared for TEI via 5000681)

1 Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K014168

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

| CA621 | |
|-------|--|
| 3D | |

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophtalmic | | | | | | | | | | E(3)<br>N(2) |
| Fetal | | E | E | E | | E | E | | E (1) | P(3)<br>N(2) |
| Abdominal | | E | E | E | | E | E | | E (1) | P(3)<br>N(2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | P(3)<br>N(2) |
| Pediatric | | E | E | E | | E | E | | E (1) | P(3)<br>N(2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | E(3)<br>N(2) |
| Cardiac | | E | E | E | | E | E | | E (1) | P(3)<br>N(2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Inhtravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | | E (1) | P(3)<br>N(2) |
| Laparoscopic | | | | | | | | | | |
| Muscoloskeletal<br>Conventional | | | | | | | | | | |
| Muscoloskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

Additional Comments:

Additional Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live;

Comomations. any combination of the rollowing modes. Bown in the modes are live.

Note (2): 3D-DSM2-DSM3

Note (2): 3D-D5M2-DSMS
Note (3): TEI (Tissue Enhanced Imaging) mode (AU6 system was cleared for TEI via K000681)

1 Prescription Use . (Per 21 CFR 801.109)

Nancy Broglon
(Division Sign-Off)

Division of Reproductive, Abdom and Radiological Devices 510(k) Number

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

| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
|------------------------------|---|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | E(3)<br>N(2) |
| Fetal | | E | E | E | | E | E | | E (1) | |
| Abdominal | | E | E | E | | E | E | | E (1) | P(3)<br>N(2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Inhtravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | | E (1) | P(3)<br>N(2) |
| Laparoscopic | | | | | | | | | | |
| Muscoloskeletal Conventional | | | | | | | | | | |
| Muscoloskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

Additional Comments:

Note ( ); Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): 3D-DSM2

F

Note (3): TEI (Tissue Enhanced Imaging) mode (AU6 system was cleared for TEI via K000681)

Prescription Use (Per 21 CFR 801.109)

Nancy brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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

| EC123 |
|-------|
| 3D |

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | E (1) | N(2) |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | E | E | E | | E | E | | E (1) | N(2) |
| Transvaginal | | E | E | E | | E | E | | E (1) | N(2) |
| Transurethral | | | | | | | | | | |
| Inhtravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscoloskeletal<br>Conventional | | | | | | | | | | |
| Muscoloskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

Additional Comments:

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): 3D-DSM2/DSM3

Prescription Use (Per 21 CFR 801.109)

ance (Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

| | 11<br>3 |
|---|---------|
| C | 2 |

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|--…