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K Number
K053530
Device Name
SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
MEDISON CO., LTD.
Date Cleared
2006-01-03

(15 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SONOACE X4 system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Vascular, Musculoskeletal applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Device Description
The SONOACE X4 is a general purpose, mobile, software controlled, diagnostic ultrasound system with on-screen display for themal and mechanical indices related to potential bioeffect mechanisms.. Its function is to acquire ultrasound data and to display the data as 2D (B) mode, M mode, Power Doppler imaging, Harmonic imaging, or 3D imaging on the CRT display.
More Information

K012887, K043455

Not Found

No
The document describes a standard ultrasound system and does not mention AI, ML, or related concepts in the device description, intended use, or performance study sections.

No
The device description states it is a "diagnostic ultrasound system" and its purpose is to "acquire ultrasound data and to display the data" for "clinical diagnosis purposes". It does not mention any therapeutic capabilities.

Yes

The "Device Description" explicitly states, "The SONOACE X4 is a general purpose, mobile, software controlled, diagnostic ultrasound system." Additionally, the "Intended Use / Indications for Use" section mentions that the analysis packages provide information "that is used for clinical diagnosis purposes."

No

The device description explicitly states it is a "diagnostic ultrasound system," which is a hardware device that acquires ultrasound data. While it is software-controlled and performs post-processing, it is not solely software.

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

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
  • Device Function: The SONOACE X4 system is described as a diagnostic ultrasound system. It transmits ultrasonic energy into patients and processes the received echoes to display images of anatomical structures and fluid flow within the body.
  • Intended Use: The intended uses listed are all related to imaging and analysis of structures within the body (General, OB, Gynecology, Abdomen, etc.).
  • No Mention of Samples: There is no mention of the device analyzing samples taken from the body.

Therefore, the SONOACE X4 system is an in vivo diagnostic device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The SONOACE X4 system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Vascular, Musculoskeletal applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX

Device Description

The SONOACE X4 is a general purpose, mobile, software controlled, diagnostic ultrasound system with on-screen display for themal and mechanical indices related to potential bioeffect mechanisms.. Its function is to acquire ultrasound data and to display the data as 2D (B) mode, M mode, Power Doppler imaging, Harmonic imaging, or 3D imaging on the CRT display.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Vascular, Musculoskeletal applications.

Indicated Patient Age Range

Adult, Pediatric, Neonatal (implied from Small Organ and Transducer Clinical Applications tables)

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K012887, K043455

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

K053530

2006 JAN 3

510(k) Premarket Notification

SONOACE X4 Diagnostic Ultrasound System

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. 997-10, 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:

November 10, 2005

2. Name of the device:

Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

SONOACE X4 Diagnostic Ultrasound System

Classification Names:FR NumberProduct Code
Ultrasonic Pulsed Doppler Imaging System892.155090-IYN
Ultrasound Pulsed Echo Imaging System892.156090-IYO
Diagnostic Ultrasound Transducer892.157090-ITX

3. Identification of the predicate or legally marketed device:

K012887, 09/12/2001, SA6000II Ultrasound system K043455, 12/21/2004, SA8000SE Ultrasound system

4. Device Description:

The SONOACE X4 is a general purpose, mobile, software controlled, diagnostic ultrasound system with on-screen display for themal and mechanical indices related to potential bioeffect mechanisms.. Its function is to acquire ultrasound data and to display the data as 2D (B) mode, M mode, Power Doppler imaging, Harmonic imaging, or 3D imaging on the CRT display.

1

The SONOACE X4 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 2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound -Equipment
  • NEMA UD 3-2004 Standard for Real Time Display of Thermal and Mechanical -Acoustic Output Indices on Diagnostic Ultrasound Equipment
  • IEC 61157, Declaration of the acoustic output -
  • ISO10993, Biocompatibility -

5. Intended Uses:

The SONOACE X4 system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Vascular, Musculoskeletal applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

6. Technological Characteristics:

The SONOACE X4 is substantially equivalent to the SA6000II Diagnostic Ultrasound System, cleared via K012887, and the SA8000 SE Diagnostic Ultrasound System, cleared via K043455. 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

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

JAN 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K053530

Trade Name: SONOACE X4 Diagnostic Ultrasound System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: IYN Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: December 15, 2005 Received: December 19, 2005

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 use with the SONOACE X4 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

HL5-9EDL5-9ECL5-9EE
C2-4ESC2-5ETC3-7ED
C4-9EDEC4-9EDEC4-9ES

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) OF N F CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing (Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) commins anaseeptarre ratus () goduction units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and r ne speerly marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

4

Page 3 - Mr. Mark Job

If you have any questions regarding the content of this letter, please contact Mr. Rodrigo Perez at (301) 594-1212.

Sincerely yours,

Daniel A. Chapman

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

Enclosures

5

510(k) Number:

Device Name: SONOACE X4 Diagnostic Ultrasound System

Device Name: "OONOROE A Diag fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(Spec.) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Abdominal | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Intra-Operative
(See Note 4) | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Small Organ
(See Note 2) | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Neonatal Cephalic | | N | N | N | | | | | Notes 1 | Note 5 |
| Adult Cephalic | | N | N | N | | | | | Notes 1 | Note 5 |
| Cardiac | | N | N | N | | | | | Notes 1 | Note 5 |
| Transesophageal | | | | | | | | | Notes 1 | |
| Trans-Rectal | | N | N | N | | | | | Notes 1 | Notes 3, 5 |
| Trans-Vaginal | | N | N | N | | | | | Notes 1 | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | N | N | | | | | Notes 1 | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Muscular-Skeletal
Superficial | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

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

Additional Comments:

Note 1: B/M, B/PW Doppler

Note 1. B/M, B/P W Dopper
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 3: Includes imaging for guidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Donald C. Hodgson

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

6

510(k) Number:

510(K) Namber .

Device Name: HL5-9ED for use with SONOACE X4

Device Name: HC9-5ED for use with SONONONOSA
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
Doppler*Power
(Amp)
DopplerColor
Velocity
ImagingCombined
(Spec.)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-Operative
(See Note 4)
Intra-Operative
NeurologicalNote 1Notes 3, 5
PediatricPPPNote 1Notes 3, 5
Small Organ
(See Note 2)PPPNote 1Notes 3, 5
Neonatal CephalicPPPNote 1Notes 3, 5
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral -VascularPPPNote 1Note 5
Laparoscopic
Muscular-Skeletal
ConventionalPPPNote 1Notes 3, 5
Muscular-Skeletal
SuperficialPPPNote 1Notes 3, 5
Others(Specify)

Mode of Oneration

N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:

Note 1: B/M, B/PW Doppler

Note 1: B/M, B/PVV Doppler
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 3: Includes imaging for guidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Daniel H. Ingram

(Division Sian-O Division of Reproductive, Abdo and Radiological Device 510(k) Number

7

510(k) Number:

Device Name: L5-9EC for use with SONOACE X4

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(Spec.) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Intra-Operative
(See Note 4) | P | P | P | N | | | | | Note 1 | Notes 5 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Small Organ
(See Note 2) | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | P | P | P | N | | | | | Note 1 | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Muscular-Skeletal
Superficial | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Others (Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K012887 ; E = added under Appendix E Additional Comments:

Note 1: B/M, B/PW Doppler

Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 3: Includes imaging for quidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David R. Lynn

(Division Sion-Of Division of Reproductive, Abdomi and Radiological Devices 510(k) Number

8

510(k) Number:

Device Name: L5-9EE for use with SONOACE X4

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(Spec.) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative
(See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Small Organ
(See Note 2) | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | P | | | | | Note 1 | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Muscular-Skeletal
Superficial | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K043455 ; E = added under Appendix E Additional Comments:

Note 1: B/M, B/PW Doppler

Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 3: Includes imaging for guidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David h. Sungum
(Division Sign-Off)

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

9

510(k) Number:

Device Name: C2-4ES for use with SONOACE X4

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
Doppler*Power
(Amp)
DopplerColor
Velocity
ImagingCombined
(Spec.)Other
(Specify)
Ophthalmic
FetalPPNNote 1Note 5
AbdominalPPNNote 1Note 5
Intra-Operative
(See Note 4)PPNNote 1Note 5
Intra-Operative
Neurological
PediatricPPNNote 1Note 5
Small Organ
(See Note 2)PPNNote 1Note 5
Neonatal CephalicPPNNote 1Note 5
Adult CephalicPPNNote 1Note 5
CardiacPPNNote 1Note 5
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral -VascularPPNNote 1Note 5
Laparoscopic
Muscular-Skeletal
Conventional
Muscular-Skeletal
Superficial
Others(Specify)

Modo nf Anarating

N = new indication; P = previously cleared in K012887 ; E = added under Appendix E Additional Comments:

Note 1: B/M, B/PW Doppler

Note 1: Dhi, Dr. V. Doppier
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 3: Includes imaging for guidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David A. Johnson

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

10

510(k) Number:

Device Name: C2-5ET for use with SONOACE X4

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
Doppler*Power
(Amp)
DopplerColor
Velocity
ImagingCombined
(Spec.)Other
(Specify)
Ophthalmic
FetalPPPNote 1Note 5
AbdominalPPPNote 1Note 5
Intra-Operative
(See Note 4)
Intra-Operative
Neurological
PediatricNNNNote 1Note 5
Small Organ
(See Note 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral - Vascular
Laparoscopic
Muscular-Skeletal
Conventional
Muscular-Skeletal
Superficial
Others(Specify)

Mode of Oneration

N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:

Note 1: B/M, B/PW Doppler

Note 1. Diw, Dr. V. Doppic.
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 3: Includes imaging for guidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Daniel H. Leyton

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

11

510(k) Number:

Device Name: C3-7ED for use with SONOACE X4

Device Name: "Oo read imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
Doppler*Power
(Amp)
DopplerColor
Velocity
ImagingCombined
(Spec.)Other
(Specify)
Ophthalmic
FetalPPPNote 1Notes 3, 5, 6
AbdominalPPPNote 1Notes 3, 5, 6
Intra-Operative
(See Note 4)PPNNote 1Notes 5, 6
Intra-Operative
Neurological
PediatricPPPNote 1Notes 3, 5, 6
Small Organ
(See Note 2)PPNNote 1Notes 3, 5, 6
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral -Vascular
Laparoscopic
Muscular-Skeletal
ConventionalPPNNote 1Notes 3, 5, 6
Muscular-Skeletal
SuperficialPPNNote 1Notes 3, 5, 6
Others(Specify)

Mode of Oneration

N = new indication; P = previously cleared in K012887 & K043455 ; E = added under Appendix E Additional Comments:

Note 1: B/M, B/PW Doppler

Note 1. Diw, Dri VV Dopper
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 3: Includes imaging for guidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David R. Symm

Division Sign Off

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

12

510(k) Number:

Device Name: C4-9ED for use with SONOACE X4

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(Spec.) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| (See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(See Note 2) | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Neonatal Cephalic | | P | P | P | | | | | Note 1 | Notes 5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Vaginal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral - Vascular | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:

Note 1: B/M, B/PW Doppler

Note 1. BM, and W Dopplic patients

Note 3: Includes imaging for guidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David K. Ingram

(Division Sian-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Numbe

Prescription Use (Per 21 CFR 801.109)

Section 4.3, Page 8

13

510(k) Number:

Device Name: EC4-9ED for use with SONOACE X4

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
Doppler*Power
(Amp)
DopplerColor
Velocity
ImagingCombined
(Spec.)Other
(Specify)
Ophthalmic
FetalPPPNote 1Notes 3, 5
Abdominal
Intra-Operative
(See Note 4)
Intra-Operative
Neurological
Pediatric
Small Organ
(See Note 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-RectalPPPNote 1Notes 3, 5
Trans-VaginalPPPNote 1Notes 3, 5
Trans-Urethral
Intra-Vascular
Peripheral-Vascular
Laparoscopic
Muscular-Skeletal
Conventional
Muscular-Skeletal
Superficial
Others (Specify)

Mode of Operation

N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:

Note 1: B/M, B/PW Doppler

Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 3: Includes imaging for guidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David R. Lyman

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

14

510(k) Number:

510(K) Nambor:
Device Name: EC4-9ES for use with SONOACE X4

Device Name: "EO4-5ES for ass w rated with thow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(Spec.) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Abdominal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Intra-Operative
(See Note 4) | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Small Organ
(See Note 2) | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Neonatal Cephalic | | P | P | P | | | | | Note 1 | Notes 5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Vaginal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Muscular-Skeletal
Superficial | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K012887; E = added under Appendix E Additional Comments:

Note 1: B/M, B/PW Doppler

Note T. B/W, B/F W Doppler
Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 3: Includes imaging for guidance of biopsy

Note 4: Abdominal organs and peripheral vessel

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Daniel R. Leyton

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