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K Number
K014168
Device Name
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2002-04-25

(127 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
Not Found
More Information

K990360, K000931

K990360, K000931

No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis based on learned patterns).

No.
The intended use explicitly states "diagnostic imaging" and does not mention any therapeutic applications.

Yes
The "Intended Use / Indications for Use" section states that the device "is intended to be used by a physician for diagnostic imaging".

No

The device is described as an "ultrasound imaging system," which inherently involves hardware components for image acquisition (transducer, processing unit, etc.), not just software.

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

Here's why:

  • Intended Use: The intended use clearly states it's an "ultrasound imaging system... for diagnostic imaging". This describes a device used to visualize internal structures of the body, which is a characteristic of medical imaging devices, not IVDs.
  • Input Imaging Modality: The input modality is "Ultrasound". Ultrasound is a non-invasive imaging technique that uses sound waves, not a method for analyzing samples of biological material.
  • Anatomical Site: The listed anatomical sites are all parts of the human body that are imaged directly. IVDs typically analyze samples taken from the body (like blood, urine, tissue).
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, assays, or any of the typical components or processes associated with in vitro diagnostics.

In summary, the description points to a medical imaging device used for visualizing the body internally, which is distinct from an in vitro diagnostic device that analyzes samples outside the body.

N/A

Intended Use / Indications for 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.

Product codes

90IYN, 90IYO, ITX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Pediatric, Small Organ (thyroid, testicles, breast), Neonatal Cephalic, Transrectal, Transvaginal, Intraoperative Abdominal, Intraoperative Peripheral Vascular, Laparoscopic, Adult Cephalic, Musculoskeletal (Conventional, Superficial)

Indicated Patient Age Range

Pediatric, Neonatal, Adult

Intended User / Care Setting

Physician

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)

Not Found

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

Not Found

Predicate Device(s)

K990360, K000931

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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
8000 Castleway Drive
Indianapolis, IN 46250
Phone:
Facsimile: | (317) 849-1916
(317) 577-9070 | |
|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------|
| Contact Person: | Colleen Hittle Densmore | |
| Date: | December 11, 2001 | |
| 807.92(a)(2) | | |
| Trade Name: | AU6 (Technos/Technos MP) Ultrasound Imaging System
(Addition of 3D Imaging Mode and Musculoskeletal
Indication) | |
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulsed doppler imaging system | 892.1550 |
| Classification Number: | 90IYN
90IYO | |
| 807.92(a)(3) | Predicate Device(s) | |
| Esaote
Esaote | AU6 (Technos/TechnosMP)
AU5 3D | K990360
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
AU5 3D
(K000931) | Esaote
AU6 Digital
(Technos)
(K990360) | Esaote
Technos/TechnosMP
This Submission
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

3

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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CA621

4

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.

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)

5

Technos /Technos™ System

3D DSM2 & DSM3 / Musculoskeletal

Appendix F

Mode of Operation
·Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
OphthalmicP (3)
FetalPPPPPP (1)N (2)
AbdominalPPPPPPP (1)P (3)
N (2)
Intraoperative AbdominalPPPPPP (1)P (3)
N (2)
Intraoperative Peripheral
vascularPPPPPP (1)P (3)
N (2)
Intraoperative NeurologicalE(3)
PediatricEEEEEEE (1)N (2)
Small Organ (specify)PPPPPP (1)P (3)
N (2)
Neonatal CephalicPPPPPPP (1)P (3)
N (2)
Adult CephalicPPPPPPP (1)P (3)
N (2)
CardiacPPPPPPP (1)P (3)
N (2)
TransesophagealPPPPPP (1)P (3)
N (2)
TransrectalPPPPPP (1)P (3)
N (2)
TransvaginalPPPPPP (1)P (3)
N (2)
Intravascular
Peripheral VascularPPPPPPP (1)P (3)
N (2)
LaparoscopicPPPPPP (1)P (3)
N (2)
Musculoskeletal ConventionalNNNNNN(1)N(3)
Muscoloskeletal SuperficialNNNNNN(1)N(2)
Other (Urological)PPPPPP (1)P (3)
N (2)
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Obstetric/Fetal
Abdominal
Intraoperative (Abdominal)EEEEEE (1)N(2)
Intraoperative (Peripheral
vascular)EEEEEE(1)N(2)
PediatricEEEEEE (1)N(2)
Small Organ (specify)EEEEEE (1)N(2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Inhtravascular
Peripheral VascularEEEEEE (1)N(2)
Laparoscopic
Muscoloskeletal ConventionalNNNNNN(1)N(2)
Muscoloskeletal SuperficialNNNNNN(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 ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricEEEEEE (1)N(2)
Small Organ (specify)EEEEEE (1)N(2)
Neonatal Cephalic
Adult Cephalic/Transcranic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Inhtravascular
Peripheral VascularEEEEEE (1)N(2)
Laparoscopic
Muscoloskeletal ConventionalNNNNNN (1)N(2)
Muscoloskeletal SuperficialNNNNNN (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 ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricEEEEEE (1)N(2)
Small Organ (specify)EEEEEE (1)N(2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Inhtravascular
Peripheral VascularEEEEEE(1)N(2)
Laparoscopic
Muscoloskeletal ConventionalNNNNNN (1)N(2)
Muscoloskeletal SuperficialNNNNNN (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 ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricEEEEEE (1)N(2)
Small Organ (specify)EEEEEE (1)N(2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Inhtravascular
Peripheral VascularEEEEEE (1)N(2)
Laparoscopic
Muscoloskeletal ConventionalNNNNNN (1)N(2)
Muscoloskeletal SuperficialNNNNNN (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 ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalEEEEEE (1)N(2)
Intraoperative (specify)
Intraoperative Neurological
PediatricEEEEEE (1)N(2)
Small Organ (specify)EEEEEE (1)N(2)
Neonatal CephalicEEEEEE (1)N(2)
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEE (1)N(2)
Laparoscopic
Muscoloskeletal
Conventional
Muscoloskeletal Superficial
Other (specify)
.
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
OphtalmicE(3)
FetalEEEEEE (1)E(3)
N(2)
AbdominalEEEEEE (1)E(3)
N(2)
Intraoperative (specify)
Intraoperative Neurological
PediatricEEEEEE (1)E(3)
N(2)
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
CardiacEEEEEE (1)E(3)
N(2)
Transesophageal
Transrectal
Transvaginal
Transurethral
IntravascularE(3)
N(2)
Peripheral VascularEEEEEE (1)E(3)
N(2)
Laparoscopic
Muscoloskeletal
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 ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
OphtalmicE(3)
N(2)
FetalEEEEEE (1)P(3)
N(2)
AbdominalEEEEEE (1)P(3)
N(2)
Intraoperative (specify)
Intraoperative NeurologicalP(3)
N(2)
PediatricEEEEEE (1)P(3)
N(2)
Small Organ (specify)
Neonatal Cephalic
Adult CephalicE(3)
N(2)
CardiacEEEEEE (1)P(3)
N(2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Inhtravascular
Peripheral VascularEEEEEE (1)P(3)
N(2)
Laparoscopic
Muscoloskeletal
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
(PW) | CWD
(CW) | Color
Doppler
(CFM) | Amplitude
Doppler
(PD) | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|------------------------------|---|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | E(3)
N(2) |
| Fetal | | E | E | E | | E | E | | E (1) | |
| Abdominal | | E | E | E | | E | E | | E (1) | P(3)
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)
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 ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalEEEEEE (1)N(2)
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalEEEEEE (1)N(2)
TransvaginalEEEEEE (1)N(2)
Transurethral
Inhtravascular
Peripheral Vascular
Laparoscopic
Muscoloskeletal
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
3 |
|---|---------|
| C | 2 |

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Inhtravascular
Peripheral VascularNNNNNN(1)N(2)
LaparoscopicEEEEEE (1)N(2)
Muscoloskeletal
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

Prescription Use
(Per 21 CFR 801.109)

Nancycbogdon
(Division Sign-Off)

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

ﺍﻟﻤﻮﺍﻗﺐ ﺍﻟﻮﺍﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ

16

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (specify)
Intra-operative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalEEEEEEEE (1)N(2)
TransvaginalEEEEEEE (1)N(2)
Transurethral
Inhtravascular
Peripheral Vascular
Laparoscopic
Muscoloskeletal
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

Prescription Use Per 21 CFR 801.109)

Nancy hogdon

(Division Sign-Off)

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

17

PA220E
3D
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalEEEEEEE (1)N (2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult CephalicEEEEEEE (1)N (2)
CardiacEEEEEEE (1)E(3)
N (2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculoskeletal
Conventional
Musculoskeletal Superficial
Other (specify)

Additional Comments:

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+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

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

Prescription Use
(Per 21 CFR 801.109)

Nancy C. Thompson

(Division Sign Off) Division of Reproductive, Abdom and Radiological Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________

18

18

PA122E 3D

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricEEEEEEEE(1)N(2)
Small Organ (specify)
Neonatal CephalicEEEEEEEE(1)N(2)
Adult Cephalic
CardiacEEEEEEEE(1)N(2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Inhtravascular
Peripheral VascularEEEEEEEE(1)N (2)
Laparoscopic
Muscoloskeletal
Conventional
Muscoloskeletal Superficial
Other (specify)

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

Additional Comments:

Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+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

Prescription Use
(Per 21 CFR 801.109)

Nancy Brogdon
(Division Sign-Off)

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