ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM

K052911 · Medison Co., Ltd. · IYN · Oct 31, 2005 · Radiology

Device Facts

• Record ID: K052911
• Device Name: ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Oct 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The ACCUVIX XQ ™ system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal (including infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal, Muscular-skeletal, Urology, TCD, Cardiac (Adult, Pediatric), and Peripheral-vascular (Carotid, Arterial, Venous) applications.

Device Story

ACCUVIX XQ is a mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via various transducers; displays 2D, M-mode, Color/Power Doppler, Harmonic imaging, PW Spectral Doppler, and 3D imaging (mechanical scan). Used in clinical settings by healthcare professionals; provides anatomical measurements and analysis packages for diagnostic purposes. System displays real-time mechanical and thermal indices. Output viewed on CRT display; assists clinicians in visualizing structures and fluid flow to inform diagnostic decisions; benefits patients through non-invasive diagnostic imaging.

Clinical Evidence

Bench testing only. The submission includes hazard analysis and compliance with recognized electromechanical safety and acoustic output standards (UL 60601-1, IEC 61157, ISO 10993). No clinical data provided.

Technological Characteristics

Mobile diagnostic ultrasound system; transducers include curved, linear, phased, and multiplane TEE arrays. Sensing via ultrasonic pulsed echo and Doppler. Energy source: electrical. Connectivity: standard ultrasound system interfaces. Software-controlled. Safety standards: UL 60601-1, C22.2 No. 601.1, EN 60601-1, EN 60601-1-2, IEC 61157, ISO 10993.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, trans-esophageal, musculoskeletal, urological, cardiac, and peripheral vascular applications. Includes guidance for biopsy.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• SONOACE 9900 PLUS (K032329)
• SONOACE 9900 (K012867)
• SONOACE 9900 (K002185)

Submission Summary (Full Text)

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#### 0C1 3 1 2005

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Prepared March 28, 2005

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)

Mr. Kyung-Am, Shim Regulatory Affairs Manager Medison Co. Ltd. 997-10, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea 82.2.2194.1381 Telephone: [phone] Facsimile: [e-mail] Email:

#### 2. Name of the device:

Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

ACCUVIX XQ TM Diagnostic Ultrasound System and Transducers

| 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:

Medison Co., Ltd. believes that ACCUVIX XQ ™ ultrasound system is substantially equivalent to the currently marketed SONOACE 9900 PLUS ultrasound system (K032329) and SONOACE 9900 ultrasound system (K012867 and K002185)

#### 4. Device Description:

The ACCUVIX XQ "M 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 CRT display. It also provides the 31) imaging mode using the 3D probe in the Mechanical scan mode.

The ACCUVIX XQ ™ has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The

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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 XQ ™ has been designed to meet the following electromechanical safety standards:

- UL 60601-1, Underwriters Laboratories Standards, Medical Electrical Equipment
- C22.2 No. 601.1, Canadian Standards Association, Medical Electrical Equipment
- EN 60601-1, European Norm, Medical Electrical Equipment
- EN 60601-1-2, European Norm, Collateral Standard: Electromagnetic Compatibility .
- IEC 61157, International Electrotechnical Commission, Requirements for the । declaration of the acoustic output of medical diagnostic ultrasonic equipment
- ISO10993, Biological evaluation of medical devices –

#### 3. Intended Uses:

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

The clinical applications include:

Fetal (including infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal, Muscular-skeletal, Urology, TCD, Cardiac (Adult, Pediatric), and Peripheral-vascular (Carotid, Arterial, Venous) applications.

#### 6. Technological Characteristics:

The ACCUVIX XQ TM is substantially equivalent to the SA-9900 PLUS Diagnostic Ultrasound System, cleared via K032329, and the SA-9900 Diagnostic Ultrasound System, cleared via K002185 and K012867. 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.

#### 7. Conclusion:

The ACCUVIX XQ™ 510(k) Pre-Market Notification contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

ACCUVIX XO™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate"

#### END of 510(K) Summary

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

OCT 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medison Co., Ltd. % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Serves NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K052911

Trade Name: ACCUVIX XQTM Diagnostic Ultrasound 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 ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 14, 2005 Received: October 17, 2005

Dear Mr. Devine:

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 ACCUVIX XQ™ Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3D3-5EK Curved Array 3D4-7EK Curved Linear Array 3D5-8EK Curved Linear Array C2-61C Curved Array

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C3-7IM Curved Array C5-2EL Curved Array CW2.0 Static CW CW4.0 Static CW EC4-9IS Curved Array L5-9EE Linear Array L5-12IM Linear Array L6-12IS Linear Array L8-I5IS Linear Array

MPT4-7AO Multiplane TEE P2-4AC Phased Array P3-5AC Phased Array P3-7AC Phased Array VAW3-5 Curved Array VAW4-7 Curved Array CDW5-8 Curved Array VNA6-12 Linear Array

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 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) clearance may not apply to the production 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 prominently 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 Rodrigo C. Perez at [phone].

Sincerely yours,

Nancyc 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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510(k) No .:

#### Section 4.3 INDICATIONS FOR USE

## DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT

| ACCUVIX XQTM 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(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<br>& 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, 8 |
| | Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 3. 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | N | N | N | N | N | | Note 7. 8 |
| | 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 | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4. 7 |
| | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4. 7 |
| | Trans-esophageal (Cardiac) | N | N | N | N | N | Note 1 | Note 7. 8 |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 5. 6, 9 |
| | Other (spec.) | | | | N | | | |

N= new indication: P= previously cleared: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Doppler Interdes Porter (Ampilate) (1997) - 1976)
Note 1 : B/M. B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

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, serotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 31) imaging

Note 9: Panoramic inkaging

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

Davie Reardon

and Radiolo 510(k) Num

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| 510(k) No .: | | | | | | | | | |
|---------------------------|-------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|-------------------|---------------------------------------------------|------------------|--|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | | | | | | | | |
| Transducer: | 3D3-5EK Curved Linear Array | | | | | | | | |
| 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal (See Note 3) | N | N | N | | N | Note 1 | Notes 2, 7, 8 | |
| | Abdominal | N | N | N | | N | Note 1 | Notes 2, 7, 8 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent) | | | | | | | | |
| | Musculo-skel (Supertic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |

N= new indication: P= previously cleared: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/ B/Color Doppler/Color M

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: theroid, parathyroid, breast, scrotum and penis in adult, pediatrie and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 31) imaging

Note 9: Panoramic imaging

Nancy broadon

(Division Sign-Off) ()
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052911

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| 510(k) No.: | |
|---------------|------------------------------------------------------------------------------------|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System |
| Transducer: | 3D4-7EK Curved Linear Array |
| 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<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | N | N | N | | N | Note I | Notes 2, 7, 8 |
| | Abdominal | N | N | N | | N | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1 : B/M. B/I/W Doppler, B/Color Doppler/PW Doppler, B/Power Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

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, pediative and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 31) imaging

Note 9: Panoramic imaging

Nansy rogo

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 1052011

Radiological Devices
510(k) Number K0529

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| 510(k) No.: | |
|---------------|------------------------------------------------------------------------------------|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System |
| Transducer: | 3D5-8EK Curved Linear Array |
| 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<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| | Ophthalmic | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | Note 1 | Notes 2. 8 | |
| | Trans-vaginal | N | N | N | | N | Note 1 | Notes 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 | Peripheral vessel | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1 : B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler. B/Color Doppler/Color M

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: 31) imaging

Note 9: Panoramic imaging

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

and Radiological Devices

510(k) Number

Nancyc Beagdon

---

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

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| 510(k) No.: | | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|---------------------------------------------------|------------------|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | | | | | | | |
| Transducer: | C2-6IC Curved Array | | | | | | | |
| 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(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<br>& 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared: E== added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Nate 1: 13/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M

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, pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D) imaging

Note 9: Panoramic imaging

Nancyc burgdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 4052911

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

| 510(k) No.: | | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|---------------------------------------------------|------------------|
| System: | ACCUVIX XQ TM Diagnostic Ultrasound System | | | | | | | |
| Transducer: | C3-7IM Curved Array | | | | | | | |
| 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | P | 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<br>& 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Doppler, B/Color Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M

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: 31) imaging

Note 9: Panoramic imaging

Nancy C. Hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices `/6R291/

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

| 510(k) No.: | | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|---------------------------------------------------|------------------|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | | | | | | | |
| Transducer: | | | | | | | C5-2EL Curved Array | |
| 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Abdominal | N | N | N | | N | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1 : B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/ B/Color Doppler/Color M

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

Nancy C. Brandon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
- Number
K052911

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

| 510(k) No.: | | | | | | | | |
|--------------------------------|------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | | | | | | | |
| Transducer:<br>CW2.0 Static CW | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| | Clinical Application | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | 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 Adult | | | | P | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | |
| | Other (spec.) | | | | P | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

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: 31) imaging

Note 9: Panoranuc imaging

Nancyc Brandon

(Division S Division of Reproc and Radiological Devices : )

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

| 510(k) No.: | ACCUVIX XQ ™ Diagnostic Ultrasound System | | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|--|---|---|-----|-----|-------------------|----------------------|------------------|
| System: | CW4.0 Static CW | | | | | | | | |
| Transducer: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Intended Use: | Clinical Application | | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& 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 | | | | N | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | N | | | | |
| | Cardiac Pediatric | | | | N | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | N | | | | |
| | Other (spec.) | | | | N | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M

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: 31) imaging

Note 9: Panoramic imaging

(Division Sid Division of Reproduc ve, A and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

| 510(k) No.: | | | | | | | | |
|---------------------------|---------------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|---------------------------------------------------|------------------|
| System: | ACCUVIX XQ ™ Diagnostic Ultrasound System | | | | | | | |
| Transducer: | EC4-9IS Curved Array | | | | | | | |
| 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<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3)<br>Abdominal<br>Intra-operative (See Note 6)<br>Intra-operative (Neuro.) | | |…