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

AI/ML Overview

This is a 510(k) premarket notification for an ultrasound imaging system. Such notifications typically focus on establishing substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria and outcome metrics like accuracy, sensitivity, or specificity.

Based on the provided document, here's what can be extracted and what cannot be determined:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for image quality or diagnostic accuracy/performance. The "reported device performance" is essentially that it is substantially equivalent to the predicate devices and supports the specified imaging modes and clinical applications.

The tables within the document (e.g., "Comparison Chart for Substantial Equivalence", and tables for individual transducers) indicate capabilities and modes of operation for various clinical applications, rather than quantifiable performance metrics against acceptance criteria.

Feature/Criterion (Implied)	Acceptance Criteria (Not explicitly stated as quantitative performance, but implied functionality)	Reported Device Performance (as presented in the 510(k) comparison)
General Characteristics
Transducer Type (Linear)	Must support Linear Array	YES (for AU6 Digital and This Submission)
Transducer Type (Convex)	Must support Convex Array	YES (for AU6 Digital and This Submission)
Transducer Type (Phased)	Must support Phased Array (for specified predicate)	YES (for AU6 Digital and This Submission)
Transducer Type (Pencil)	Must support Pencil (for specified predicate)	YES (for AU6 Digital and This Submission)
Imaging Modes
B Mode	Must support B Mode	YES (for AU6 Digital and This Submission)
M Mode	Must support M Mode	YES (for AU6 Digital and This Submission)
PWD (PW)	Must support PWD (PW)	YES (for AU6 Digital and This Submission)
CWD	Must support CWD (for specified predicate)	YES (for AU6 Digital and This Submission)
Color Doppler (CFM)	Must support CFM	YES (for AU6 Digital and This Submission)
Amplitude Doppler (PD)	Must support PD	YES (for AU6 Digital and This Submission)
Combined Modes	Must support Combined Modes	YES (for AU6 Digital and This Submission)
Duplex	Must support Duplex	YES (for AU6 Digital and This Submission)
Triplex	Must support Triplex	YES (for AU6 Digital and This Submission)
TEI/CTEI	Must support TEI/CTEI	YES (for AU6 Digital and This Submission)
3D (Module)	Must support 3D imaging (for AU5 3D and This Submission)	YES (for AU5 3D and This Submission)
Clinical Applications (New/Added)	Functionality for Musculoskeletal Conventional and Superficial	N (New) - the device specifically adds these applications to the AU6 model. Performance is implied to be equivalent to safely and effectively enable these applications.
Functionality for 3D Imaging	Functionality for 3D imaging across various clinical applications.	N (New) or P (Previously Cleared) / E (Added under Appendix) depending on the specific transducer and application, for 3D-DSM2/DSM3 mode.
Safety and Standards	Compliance with IEC 60601-1 and Track 3 for Ultrasound safety	IEC 60601-1, Track 3 (Reported as compliant to the same standards as predicate devices)

2. Sample Size for the Test Set and Data Provenance:

The document does not provide any information about a specific "test set" in the context of an accuracy study. This submission is a 510(k) for an ultrasound imaging system, which primarily demonstrates substantial equivalence through technical comparison and compliance with performance standards (e.g., electrical safety, acoustic output), rather than clinical performance studies against a gold standard for specific diagnostic tasks. The "data provenance" for a clinical test set is therefore unstated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided as there is no mention of a clinical performance study with a test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not provided as there is no mention of a clinical performance study with a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not report on an MRMC comparative effectiveness study, nor does it mention any effect size of human readers improving with AI vs. without AI assistance. This device is an ultrasound imaging system, not an AI-powered diagnostic aide in the context of this submission.

6. Standalone (Algorithm Only) Performance Study:

The document does not report on a standalone performance study. The device is an ultrasound imaging system, where its "performance" for 510(k) purposes is largely demonstrated through technical specifications and adherence to safety and performance standards.

7. Type of Ground Truth Used:

As no clinical performance study with a "test set" is described, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set:

The document does not provide any information about a training set. This is not an AI/machine learning device in the context of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided as no training set is mentioned.

Summary of the Study (Based on the 510(k) provided):

The "study" presented in this 510(k) is a substantial equivalence comparison. The manufacturer, Biosound Esaote, sought clearance for the AU6 (Technos/Technos MP) Ultrasound Imaging System with the addition of 3D Imaging Mode and Musculoskeletal Indication.

The study primarily involves a technical comparison of the proposed device (AU6 Technos/Technos MP with 3D/Musculoskeletal additions) against predicate devices: the Esaote AU5 3D (K000931) for 3D capabilities and the Esaote AU6 Digital (Technos K990360) for general ultrasound capabilities.

The "acceptance criteria" are implicitly met if the new device demonstrates similar technological characteristics and performance specifications for the modes and applications it claims, and meets relevant electrical and ultrasound safety standards (IEC 60601-1 and Track 3 for Ultrasound safety). The performance is "reported" by affirming the device's capabilities match or are comparable to the predicates for the cleared indications and modes, while explicitly highlighting the new applications (Musculoskeletal Conventional, Musculoskeletal Superficial, and 3D imaging in certain contexts) as additions with these capabilities. The FDA's letter of clearance confirms that the device is "substantially equivalent" for the stated indications for use.

Summary

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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 Correspondent8000 Castleway DriveIndianapolis, IN 46250Phone: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 MusculoskeletalIndication)
Common Name:	Ultrasound Imaging System
Classification Name(s):	Ultrasonic pulsed doppler imaging system	892.1550
Classification Number:	90IYN90IYO
807.92(a)(3)	Predicate Device(s)
EsaoteEsaote	AU6 (Technos/TechnosMP)AU5 3D	K990360 K000931

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

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

807.92(a)(5)

Intended Use(s)

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510(k) Summary

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

General Characteristic	EsaoteAU5 3D(K000931)	EsaoteAU6 Digital(Technos)(K990360)	EsaoteTechnos/TechnosMPThis Submission3D/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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 (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)

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Technos /Technos™ System

3D DSM2 & DSM3 / Musculoskeletal

Appendix F

	Mode of Operation
·Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(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)N (2)
Intraoperative Abdominal		P	P	P		P	P		P (1)	P (3)N (2)
Intraoperative Peripheralvascular		P	P	P		P	P		P (1)	P (3)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)N (2)
Neonatal Cephalic		P	P	P	P	P	P		P (1)	P (3)N (2)
Adult Cephalic		P	P	P	P	P	P		P (1)	P (3)N (2)
Cardiac		P	P	P	P	P	P		P (1)	P (3)N (2)
Transesophageal		P	P	P		P	P		P (1)	P (3)N (2)
Transrectal		P	P	P		P	P		P (1)	P (3)N (2)
Transvaginal		P	P	P		P	P		P (1)	P (3)N (2)
Intravascular
Peripheral Vascular		P	P	P	P	P	P		P (1)	P (3)N (2)
Laparoscopic		P	P	P		P	P		P (1)	P (3)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)N (2)


	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Obstetric/Fetal
Abdominal
Intraoperative (Abdominal)		E	E	E		E	E		E (1)	N(2)
Intraoperative (Peripheralvascular)		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

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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(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(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

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LA522E

3D & Musculoskeletal

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(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(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(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

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

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(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
MuscoloskeletalConventional
Muscoloskeletal Superficial
Other (specify)

.
	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophtalmic										E(3)
Fetal		E	E	E		E	E		E (1)	E(3)N(2)
Abdominal		E	E	E		E	E		E (1)	E(3)N(2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		E	E	E		E	E		E (1)	E(3)N(2)
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		E	E	E		E	E		E (1)	E(3)N(2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular										E(3)N(2)
Peripheral Vascular		E	E	E		E	E		E (1)	E(3)N(2)
Laparoscopic
MuscoloskeletalConventional
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(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophtalmic										E(3)N(2)
Fetal		E	E	E		E	E		E (1)	P(3)N(2)
Abdominal		E	E	E		E	E		E (1)	P(3)N(2)
Intraoperative (specify)
Intraoperative Neurological										P(3)N(2)
Pediatric		E	E	E		E	E		E (1)	P(3)N(2)
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic										E(3)N(2)
Cardiac		E	E	E		E	E		E (1)	P(3)N(2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Inhtravascular
Peripheral Vascular		E	E	E		E	E		E (1)	P(3)N(2)
Laparoscopic
MuscoloskeletalConventional
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	B	M	PWD(PW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	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

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(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(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
MuscoloskeletalConventional
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}------------------------------------------------

	113
C	2

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(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 Vascular		N	N	N		N	N		N(1)	N(2)
Laparoscopic		E	E	E		E	E		E (1)	N(2)
MuscoloskeletalConventional
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 Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	Color VelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (specify)
Intra-operative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	E	E	E	E	E	E	E		E (1)	N(2)
Transvaginal	E	E	E	E		E	E		E (1)	N(2)
Transurethral
Inhtravascular
Peripheral Vascular
Laparoscopic
MuscoloskeletalConventional
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 Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		E	E	E	E	E	E		E (1)	N (2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		E	E	E	E	E	E		E (1)	N (2)
Cardiac		E	E	E	E	E	E		E (1)	E(3)N (2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
MusculoskeletalConventional
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}------------------------------------------------

PA122E 3D

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric	E	E	E	E	E	E	E		E(1)	N(2)
Small Organ (specify)
Neonatal Cephalic	E	E	E	E	E	E	E		E(1)	N(2)
Adult Cephalic
Cardiac	E	E	E	E	E	E	E		E(1)	N(2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Inhtravascular
Peripheral Vascular	E	E	E	E	E	E	E		E(1)	N (2)
Laparoscopic
MuscoloskeletalConventional
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 __

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.