The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Abdomen, OB, Gynecology, Contrast Agent, Small parts, Vascular, Muscular-skeletal, Pediatric Abdomen, Adult Cardiac, Pediatric Cardiology, TCD, Urology, Cardiac applications.

Device Description

The ACCUVIX V10 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the LCD display. It also provides the 3D imaging mode using the 3D probe in the Mechanical scan mode. The ACCUVIX V10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

AI/ML Overview

The provided text is a 510(k) summary for the ACCUVIX V10 Diagnostic Ultrasound System and its associated transducers. The document describes the device, its intended uses, and lists safety standards it has been designed to meet. However, it does not contain information about specific acceptance criteria or performance studies in the context of clinical efficacy or accuracy for the device itself or any AI components.

The tables within the document (e.g., in {4}-{27}) are "INDICATIONS FOR USE" statements for the main device and its various transducers. These tables specify the clinical applications and mode of operation ("B" for B-mode, "M" for M-mode, "PWD" for Pulsed Wave Doppler, "CWD" for Continuous Wave Doppler, "Color Doppler*", "Combined*", and "Other (Spec.)") for which each transducer is intended. The "P" indicates "previously cleared by FDA" for that specific indication, mode, and transducer combination, while "N" indicates a "new indication" for the overall system or a specific transducer. This is not performance data, but rather a catalog of approved uses.

Therefore, I cannot fulfill the request to provide:

A table of acceptance criteria and the reported device performance: The document does not provide acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy) or reported performance against such criteria.
Sample size used for the test set and the data provenance: No clinical study data, sample sizes, or data provenance (country, retrospective/prospective) are mentioned.
Number of experts used to establish the ground truth... and their qualifications: Not applicable as no ground truth creation process is described.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
Standalone performance (algorithm only): Not applicable as the document describes a diagnostic ultrasound system, not an AI algorithm with standalone performance.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable as no training data for an AI algorithm is mentioned.
How the ground truth for the training set was established: Not applicable.

The document focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices (K052911, K063580, K032329, K060087, K43455, K053530 depending on the specific transducer). This means the device is considered as safe and effective as a legally marketed device without necessarily requiring new clinical performance studies if the technological characteristics and intended uses are sufficiently similar. The "performance" mentioned in the document relates to meeting general product safety standards (UL, CSA, IEC, EN/IEC, NEMA, ISO), but these are not clinical performance acceptance criteria in the sense of accuracy, sensitivity, or specificity for diagnostic tasks.

Summary

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Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically "K070813". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The contrast between the characters and the background is high, making them easily readable.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1. Submitter's Information: 21 CFR 807.92(a)(1)

MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea

Contact Person: Mr. Kyung-Am, Shim Regulatory Affairs Manager

Telephone:	82.2.2194.1381
Facsimile:	82.2.2194.1399
Email:	kashim@medison.com

Data Prepared: March 15, 2007

2. Name of the device:

Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

ACCUVIX V10 Diagnostic Ultrasound System

Classification Names:	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasound Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

3. Identification of the predicate or legally marketed device:

K052911, 10/31/2005, ACCUVIX XQ Diagnostic Ultrasound System K063580, 12/14/2006, SONOACE X8 Diagnostic Ultrasound System

4. Device Description:

The ACCUVIX V10 has real time acoustic output display with two basic indices, a

510(k) Summary of Safety and Effectiveness

ATTACHMENT 1(b)

APR 1 0 2007

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

mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The ACCUVIX V10 has been designed to meet the following product safety standards:

UL 60601-1, Safety requirements for Medical Equipment
CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
IEC60601-2-37, Diagnostic Ultrasound Safety Standards
EN/IEC60601-1, Safety requirements for Medical Equipment
EN/IEC60601-1-2, EMC requirements for Medical Equipment y
NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
IEC 61157, Declaration of the acoustic output
ISO10993-1. Biocompatibility

5. Intended Uses:

The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include:

Abdomen, OB, Gynecology, Contrast Agent, Small parts, Vascular, Muscular-skeletal, Pediatric Abdomen, Adult Cardiac, Pediatric Cardiology, TCD, Urology, Cardiac applications.

6. Technological Characteristics:

The ACCUVIX V10 is substantially equivalent to the ACCUVIX XQ Diagnostic Ultrasound System, cleared via K052911, and the SONOACE X8 Diagnostic Ultrasound System, cleared via K063580. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

END of 510(K) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medison Co., Ltd. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

APR 1 0 2007

Re: K070813

Trade Name: ACCUVIX V10 Diagnostic Ultrasound System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO and ITX Dated: March 23, 2007 Received: March 26, 2007

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for ACCUVIX V10 Diagnostic Ultrasound System, as described in your premarket use with the notification:

Transducer Model Number

3D2-5EH	3D2-5EL	3D2-6ET	3D4-8ET	3D4-9ES	C1-4EC
C2-5EL	C2-6IC	C3-7IM	C4-9/10ED	EC4-9IS	NER4-9ES
NEV4-9ES	L4-7EH	L5-12/50EP	L5-12ID	L6-12IS	L8-15IS
P2-4AC	P3-5AC	P3-7AC	CW 2.0	CW 4.0

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

Page 2 - Mr. Mark Job

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact John Chen, Ph.D., at (240) 276-3666.

Sincerely yours,

David R. Ingram

for

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

Enclosures

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

Section 4.3 INDICATIONS FOR USE

DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT

510(k) No .: Device Name:

ACCUVIX V10 Diagnostic Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N	N	N	Note 1	Notes 2, 7, 8
	Abdominal	N	N	N	N	N	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 2,4,5,6,7,8,9
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Note 2,5,6,8,9
	Neonatal Cephalic	N	N	N	N	N	Note 1
	Adult Cephalic	N	N	N	N	N	Note 1	Note 4, 7
	Trans-rectal	N	N	N	N	N	Note 1	Note 2, 3, 7, 8
	Trans-vaginal	N	N	N	N	N	Note 1	Note 2, 3, 7, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1	Note 2,5,6,8,9
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1	Note 2,5,6,8,9
	Intra-luminal
	Other (spec.)
	Cardiac Adult	N	N	N	N	N	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	N	N	N	N	N	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	Note 1	Note 5, 6, 9
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

David h. Gyson

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

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

510(k) No .:

Device Name: 3D2-5EH for use with ACCUVIX V10

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Intended Use:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P	P	P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler:M, B/Color Doppler/M, B/Color Doppler/CWD Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

David A. Ingram

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

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

510(k) No .:

Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

580; E= added under Appendix E new indication: P= previously cleared

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Daniel R. Szymon

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

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

510(k) No.:
Device Name:	3D2-6ET for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
	Peripheral vessel
PeripheralVessel	Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

David A. Hyman

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

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

510(k) No.:

Device Name: 3D4-8ET for use with ACCUVIX V10

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation (includes simultaneous B-mode) General Specific B M PWD CWD Color Combined Other (Tracks I & III) (Track I only) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) P p P P Note 1 Notes 2, 7, 8 Abdominal Note 1 Notes 2, 7, 8 P P P P Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic Pediatric & Other Notes 2, 7, 8 P P P P Note l Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

David A. Sayre

(Division Sian-Off) ision of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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

510(k) No.:
Device Name:	3D4-9ES for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
		B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Specific(Tracks I & III)
	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 7, 8
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7. 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Ingram

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

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

510(k) No.:
Device Name:	C1-4EC for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared under K060087; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Daniel A. Rogers

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

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

510(k) No.:Device Name:	C2-5EL for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared under K032329 and K052911; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Daniel A. Hagerman

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

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

510(k) No.:
Device Name:	C2-6IC for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	Color• Doppler*	Combined*(Spec.)	Other(Spec.)
	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

K052911; E= added under Appendix E pi

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: BM, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David A. Symon

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

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

510(k) No .:

Device Name:	C3-7IM for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared under K032329 and K052911; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

David A. Symm

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

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

510(k) No .:

Device Name:	C4-9/10ED for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
General	Specific	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Note 2, 8
	Abdominal	P	P	P		P	Note 1	Note 2, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 8
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 8
	Neonatal Cephalic	P	P	P		P	Note 1	Note 2, 8
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 8
	Other (spec.)

N= new indication; P= previously cleared under K43455 and K053530; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Preseription Use (Per 21 CFR 801.109)

Elvin le Segnern

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

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

510(k) No .:

Device Name:	EC4-9IS for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared under K032329 and K052911; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Edward A. Ingram

ision Sign-Off) sion of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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

510(k) No.:
Device Name:	NER4-9ES for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	Color Doppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal ( See Note 3 )
	Abdominal
	Intra-operative ( See Note 6 )
	Intra-operative (Neuro.)
Fetal Imaging & Other	Laparoscopic
	Pediatric
	Small Organ ( See Note 5 )
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 8
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.10

Daniel K. Inouye

(Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Numbe

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

510(k) No .:

NEV4-9ES for use with ACCUVIX V10 Device Name:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Mode of Operation (includes simultaneous B-mode) Clinical Application PWD CWD Combined Other Specific B M Color General (Tracks I & III) Doppler* (Spec.) (Spec.) (Track I only) Ophthalmic Ophthalmic Fetal (See Note 3)

	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	Note 1	Note 2, 8
	Trans-vaginal	P	P	P	P	Note 1	Note 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler:M, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David Lennon

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

{18}------------------------------------------------

510(k) No.:
Device Name:	L4-7EH for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation (*includes simultaneous B-mode)
	General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)
	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 9
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 5, 6, 9
	Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

David de Segarra

{19}------------------------------------------------

510(k) No .:

Device Name: L5-12/50EP for use with ACCUVIX V10 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation (includes simultaneous B-mode) General Specific B M PWD CWD Color Combined Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic & Other Pediatric P P P P Note 2, 5, 6, 7, 9 Note l Small Organ (See Note 5) P P P P Note 1 Note 2, 5, 6, 7, 9 Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) P Note 2, 5, 6, 7, 9 p P P Note 1 Musculo-skel. (Superfic.) P P P Note 2, 5, 6, 7, 9 P Note l Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Note 2, 5, 6, 7, 9 P P P P Note 1 Vessel Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David Le Segura

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

{20}------------------------------------------------

510(k) No .:

Device Name:	L5-12ID for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 9
Vessel	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Prescription Use (Per 21 CFR 801.1

Daniel G. Benner

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

{21}------------------------------------------------

510(k) No.:
Device Name:	L6-12IS for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation (*includes simultaneous B-mode)Clinical Application
General	Specific	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Other (spec.)

N= new indication; P= previously cleared under K052911; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Daniel br. Lynn

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

{22}------------------------------------------------

510(k) No.:
Device Name:	L8-15IS for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
Fetal Imaging& Other	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)

PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 9
	Other (spec.)

N= new indication; P= previously cleared under K052911; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) · Prescription Use (Per 21 CFR 801.109)

Florind A. Simpson

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

{23}------------------------------------------------

510(k) No .:

P2-4AC for use with ACCUVIX V10 Device Name: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal ( See Note 3 )
	Abdominal	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative ( See Note 6 )
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ ( See Note 5 )
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared under K052911 and K060087; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Daniel A. Ingram

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

{24}------------------------------------------------

510(k) No .:

Device Name:	P3-5AC for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by K052911 and K06008; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Daniel R. Lyman
(Division Sign-Off)

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

{25}------------------------------------------------

510(k) No.:
Device Name:	P3-7AC for use with ACCUVIX V10
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by K052911 and K06008; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

David h. Simpson

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

{26}------------------------------------------------

510(k) No .:

Device Name:		CW 2.0 for use with ACCUVIX V10
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	B	M	PWD	CWD	Color Doppler*	Combined* (Spec.)	Other (Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic			P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult			P
	Cardiac Pediatric			P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel			P
	Other (spec.)

N= new indication; P= previously cleared K052911 and K06008; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

David A. Logemann

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

{27}------------------------------------------------

510(k) No.:
Device Name:	CW 4.0 for use with ACCUVIX V10
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General (Track I only)	Specific (Tracks I & III)	B	M	PWD	CWD	Color Doppler*	Combined* (Spec.)	Other (Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic				P
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral Vessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by K052911 and K06008; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

どで

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Daniel R. Larson

(Division Sign-Off) Division of Reproductive, Abdominal, 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.