FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB

K110202 · Fujifilm Medical System U.S.A., Inc. · ITX · Feb 8, 2011 · Radiology

Device Facts

• Record ID: K110202
• Device Name: FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: ITX · Radiology
• Decision Date: Feb 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The system is intended for use by a qualified physician for ultrasound evaluation of Fetal/obstetric, gynecological, Abdominal (renal, GYN/Pelvic), Pediatric, Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic, Trans-vaginal, Trans-cranial, Musculoskeletal (conventional & superficial), Cardiac-Adult/Pediatric/Fetal, Pelvic, Peripheral vascular, and harmonic tissue.

Device Story

The FUJIFILM Diagnostic Ultrasound System FAZONE CB is a portable, general-purpose diagnostic ultrasound imaging system. It consists of a main unit, battery, and various compatible ultrasound probes. The system features a touch-panel control interface with a virtual keyboard. It is designed for use by qualified physicians in clinical settings to perform ultrasound evaluations across multiple anatomical regions. The device processes ultrasound signals to produce real-time diagnostic images and fluid flow analysis (Doppler). Optional components, such as a cart, external monitor, and printer, can be integrated. The system aids clinicians in visualizing internal structures and blood flow, supporting diagnostic decision-making for a wide range of clinical applications.

Clinical Evidence

No clinical test was conducted. The device's safety and performance were evaluated through bench testing in accordance with international standards, including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, ISO 10993, and ISO 14971.

Technological Characteristics

Portable ultrasound system with touch-panel interface. Supports B-mode, M-mode, PWD, and Color/Power Doppler imaging. Compatible with various transducers (linear, phased/sector array, curvilinear, endo-cavity). Connectivity includes DICOM standards. Safety compliance per IEC 60601 series. Software life cycle managed per IEC 62304.

Indications for Use

Indicated for ultrasound evaluation of fetal/obstetric, gynecological, abdominal, pediatric, small organ, adult/neonatal cephalic, trans-vaginal, trans-cranial, musculoskeletal, cardiac, pelvic, and peripheral vascular applications in patients requiring diagnostic ultrasound imaging or fluid flow analysis.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• ZONARE z.one Ultra Ultrasound System (K101091)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the main logo, the text "Fujifilm Medical Systems, USA" is written in a smaller font. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.

# FEB - 8 2011

K110202

## 510(k) Summarv FUJIFILM Diagnostic Ultrasound System FAZONE CB ·

#### Date: January 6, 2011

#### Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA

#### Contact Person:

| Name: | Katherine Y. Choi, RAC |
|------------|-------------------------------|
| Title: | Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Facsimile: | [phone] |

### ldentification of the Candidate Device:

Proprietary/Trade Name: Common Name: Device Class: Review Panel:

FUJIFILM Diagnostic Ultrasound System FAZONE CB Diagnostic Ultrasound System Class 2 Radiology

Classification Information:

| Classification Name | CFR Section | Product Codes |
|------------------------------------------|-----------------|---------------|
| Ultrasonic Pulsed Doppler Imaging System | 21 CFR 892.1550 | 90 IYN |
| Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 | 90 IYO |
| Diagnostic Ultrasonic Transducer | 21 CFR 892.1570 | 90 ITX |

#### l. INDICATIONS FOR USE

The system is intended for use by a qualified physician for ultrasound evaluation of Fetal/obstetric, gynecological, Abdominal (renal, GYN/Pelvic), Pediatric, Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic, Trans-vaginal, Trans-cranial, Musculoskeletal (conventional & superficial), Cardiac-Adult/Pediatric/Fetal, Pelvic, Peripheral vascular, and harmonic tissue.

#### ll. DEVICE DESCRIPTION

The candidate device, FUJIFILM Diagnostic Ultrasound System FAZONE CB, is a general purpose ultrasound diagnostic imaging equipment, which features the compact design suitable for easy transport. The FAZONE CB system generally includes a portable CB main unit, battery, and ultrasound probes. The FAZONE CB compatible ultrasound probes are connected directly to the CB main unit. The control panel of the CB main unit utilizes a touch panel for ease of use providing a virtual keyboard. Optional parts and other system components - for example, external monitor, printer, keyboard, etc. - can be connected to the CB main unit. The CB cart (optional) provides

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

. " . " :

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Image /page/1/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The word "FUJIFILM" is written in large, bold, black letters. Below the main logo, the words "Fujifilm Medical Systems, USA" are written in a smaller, sans-serif font, also in black. The logo is simple and professional, conveying a sense of reliability and technological expertise.

a docking station for the CB main unit and accommodates optional parts and other system components when they are connected to the CB main unit. The CB main unit can be used without the CB cart.

#### SUMMARY OF STUDIES lll.

The FUJFILM Diagnostic Ultrasound System FAZONE CB was evaluated in accordance with following safety and performance requirements in addition to the applicable quality system regulations:

| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for safety |
|----------------|----------------------------------------------------------------------------|
| IEC 60601-1-1 | Medical electrical equipment - Part 1-1: General requirements for safety - |
| | Collateral standard: Safety requirements for medical electrical systems |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for safety - |
| | Collateral standard: Electromagnetic compatibility |
| IEC 60601-2-37 | Medical electrical equipment - Part 2-37: Particular requirements for the |
| | basic safety and essential performance of ultrasonic medical diagnostic |
| | and monitoring equipment |
| IEC 62304 | Medical device software - Software life cycle processes |
| IEC 62366 | Medical devices - Application of usability engineering to medical devices |
| ISO 10993 | Biological evaluation of medical devices |
| DICOM | Digital Imaging and Communications in Medicine (DICOM) |
| ISO 14971 | Medical devices – Application of risk management to medical devices |

No clinical test was conducted.

#### IV. SUBSTANTIAL EQUIVALENCE

The FUJIFILM Diagnostic Ultrasound System FAZONE CB is substantially equivalent to the following device: .

| Legally Marketed Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| . ZONARE z.one Ultra Ultra Ultrasound System | K101091 |

The candidate and marketed devices utilize similar technology and materials, comparable safety and effectiveness features, and they are similar in design and construction. The Indications for Use and labeling are similar and our labeling contains the required Cautions, Warnings and Contraindications consistent to those required for similar marketed device.

#### V. CONCLUSION

The FUJIFILM Diagnostic Ultrasound System FAZONE CB is substantially equivalent to the legally marketed device and conforms to applicable medical device safety and performance standards.

।

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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 depiction of an eagle or bird with outstretched wings, rendered in a simple, flowing line drawing. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters, arranged around the circumference of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Fujifilm Medical Systems USA. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313

FEB - 8 2011

Re: K110202

Trade/Device Name: FUJIFILM Diagnostic Ultrasound System FAZONE CB Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: ITX, IYN, and IYO Dated: January 21, 2011 Received: January 24, 2011

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 FUJIFILM Diagnostic Ultrasound System FAZONE CB, as described in your premarket notification:

### Transducer Model Number

FZT E9-4 (Endo-Cavity Probe) FZT L10-5 (Linear Probe) FZT P4-1c (Phased/Sector Array Probe) FZT L8-3 (Linear Probe) FZT P4-1 (Phased Array Probe)

FZT P10-4 (Phased/Sector Array Probe) FZT C6-2 (Curvilinear Probe) FZT C9-3 (Curvilinear Probe) FZT L14-5sp (Linear Probe) FZT L14-5w (Linear Probe)

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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 895. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Paul Hardy at [phone].

closure(s)

Sincerely Yours,

Mary Sparts

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indications For Use Statement

510(k) Number (If Known):

Device Name: FUJIFILM Diagnostic Ultrasound System FAZONE CB

Indications for Use:

The system is intended for use by a qualified physician for ultrasound evaluation of Fetal/obstetric, gynecological, Abdominal (renal, GYN/Pelvic), Pediatric, Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic, Trans-vaginal, Trans-cranial, Musculoskeletal (conventional & superficial), Cardiac-Adult/Pediatric/Fetal, Pelvic, Peripheral vascular, and harmonic tissue.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mun S. Pastt
(Division Sign-Off)

Division of Radiological Device Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110202

CONFIDENTIAL

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

Page 44 of 1519

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510(k) Number (If Known):

System Name: FUJIFILM Diagnostic Ultrasound System FAZONE CB Transducer: With All Transducers

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

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler2 | Combined3 | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal4 | N | N | N | | N | N | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | N | N | N | | | N | |
| | Neonatal Cephalic | N | N | N | | N | N | |
| General | Adult Cephalic | N | N | N | | N | N | |
| Application | Trans-rectal | | | | | | | |
| | Trans-vaginal | N | N | N | | N | N | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N1 | N | N | | N | N | |
| | Cardiac Pediatric | N | N | N | | N | N | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | |
| Vessel | Other (Specify) | | | | | | | |

= previously cleared by FDA; E = added under this appendix

1 Includes B-Mode and Harmonic Imaging (HI)

2 Includes Color Doppler (CD) and Power Doppler (PD)

Includes B+M, B+CD+PWD where CD would represent (CD or PD)

Abdominal includes renal, GYN/Pelvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mery S. Phat
(Division Sign-Off)

ce Evaluation and Safety Office of In

510K. K110202

CONFIDENTIAL

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

Page 45 of 1519

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510(k) Number (If Known):

FUJIFILM Diagnostic Ultrasound System FAZONE CB System Name: Transducer: EZT E9-4 (Endo-Cavity Probe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler2 | Combined3 | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal4 | | | | | | | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| General | Adult Cephalic | | | | | | | |
| Application | Trans-rectal | | | | | | | |
| | Trans-vaginal | N | N | N | | N | N | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (Specify) | | | | | | | |

viously cleared by FDA; E = added under this appendix

Includes B-Mode and Harmonic Imaging (HI)

Includes Color Doppler (CD) and Power Doppler (PD)

Includes B+M, B+CD+PWD where CD would represent (CD or PD)

Abdominal includes renal, GYN/Pelvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Slatts
(Division Sign Off)

Office of In on and Safety

510K K110202

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

.

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

510(k) Number (If Known):

FUJIFILM Diagnostic Ultrasound System FAZONE CB System Name: Transducer: FZT L10-5 (Linear Probe)

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

| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|--|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler2 | Combined3 | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | | |
| | Abdominal4 | N | N | N | | N | N | | |
| | Intra-operative | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | N | N | N | | N | N | | |
| | Neonatal Cephalic | N | N | N | | N | N | | |
| General | Adult Cephalic | | | | | | | | |
| Application | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | | |
| | Musculo-skeletal | N | N | N | | N | N | | |
| | (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | | |
| Vessel | Other (Specify) | | | | | | | | |

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

1 Includes B-Mode and Harmonic Imaging (HI)

2 Includes Color Doppler (CD) and Power Doppler (PD)

3 Includes B+M, B+CD+PWD where CD would represent (CD or PD)

4 Abdominal includes renal, GYN/Pelvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

ice of In Vitro Djagnostic Devices (OIVD) Concurrence of CDRH, Of

Murry Slater

Office of In

610K K110202

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

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

510(k) Number (If Known):

System Name: FUJIFILM Diagnostic Ultrasound System FAZONE CB Transducer:

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

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler² | Combined³ | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal⁴ | N | N | N | . | N | N | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | N | N | N | | N | N | |
| General | Adult Cephalic/<br>Trans-cranial | N | N | N | | N | N | |
| Application | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N¹ | N | N | | N | N | |
| Cardiac | Cardiac Pediatric | N | N | N | | N | N | |
| | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | |
| Vessel | Other (Specify) | | | | | | | |

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

Includes B-Mode and Harmonic Imaging (HI)

2 Includes Color Doppler (CD) and Power Doppler (PD)

3 Includes B+M, B+CD+PWD where CD would represent (CD or PD)

4 Abdominal includes renal, GYN/Pelvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Giagnogtic Devices (OIVD)

Office of In Vitro Evaluation and Safety

510K K110202

CONFIDENTIAL

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

Page 48 of 1519

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510(k) Number (If Known):

FUJIFILM Diagnostic Ultrasound System FAZONE CB System Name: Transducer: FZT L8-3 (Linear Probe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler² | Combined³ | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal⁴ | N | N | N | | N | N | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | N | N | N | | N | N | |
| | Neonatal Cephalic | N | N | N | | N | N | |
| General | Adult Cephalic | | | | | | | |
| Application | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N ~ | |
| Vessel | Other (Specify) | | | | | | | |

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

Includes B-Mode and Harmonic Imaging (HI)

Includes Color Doppler (CD) and Power Doppler (PD)

Includes B+M, B+CD+PWD where CD would represent (CD or PD)

: :

Abdominal includes renal, GYN/Pelvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mury S/Vasta
(Division Sign-Off)

Division of Radiological Devices
Office In Vitro Diagnostic Device Evaluation and Safety

CONFIDENTIAL

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

SIOK

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

510(k) Number (If Known):

FUJIFILM Diagnostic Ultrasound System FAZONE CB System Name: Transducer: FZT P4-1 (Phase/Sector Array Probe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler² | Combined³ | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal⁴ | N | N | N | | N | N | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | N | N | N | | N | N | |
| General | Adult Cephalic/<br>Tran-cranial | N | N | N | | N | N | |
| Application | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N | N | N | | N | N | |
| | Cardiac Pediatric | N | N | N | | N | N | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | | Intra-cardiac | | | | | | |
| | | Other (Specify) | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | |
| Vessel | Other (Specify) | | | | | | | |

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

Includes B-Mode and Harmonic Imaging (HI)

Includes Color Doppler (CD) and Power Doppler (PD)

Includes B+M, B+CD+PWD where CD would represent (CD or PD)

Abdominal includes renal, GYN/Pelvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Stastil

(Division Sign-Off)
Division of Radiological Devices

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110202

CONFIDENTIAL

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

Page 50 of 1519

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

510(k) Number (If Known):

FUJIEILM Diagnostic Ultrasound System FAZONE CB System Name: Transducer: FZT P10-4 (Phase/Sector Array Probe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|------------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler2 | Combined3 | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal4 | N | N | N | | N | N | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | N | N | N | | N | N | |
| General<br>Application | Adult Cephalic/<br>Tran-cranial | N | N | N | | N | N | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N | N | N | | N | N | |
| Cardiac | Cardiac Pediatric | N | N | N | | N | N | |
| | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | |
| | Other (Specify) | | | | | | | |

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

Includes B-Mode and Harmonic Imaging (HI)

Includes Color Doppler (CD) and Power Doppler (PD)

Includes B+M, B+CD+PWD where CD would represent (CD or PD)

Abdominal includes renal. GYN/Pelvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
CONFIDENTIAL

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

11/11/

510K

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

510(k) Number (If Known):

FUJIFILM Diagnostic Ultrasound System FAZONE CB System Name: Transducer: FZT C6-2 (Curvilinear Probe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler2 | Combined3 | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal4 | N | N | N | | N | N | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| General | Adult Cephalic | | | | | | | |
| Application | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | N | N | N | |
| Vessel | Other (Specify) | | | | | | | |

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

Includes B-Mode and Harmonic Imaging (HI)

Includes Color Doppler (CD) and Power Doppler (PD)

Includes B+M, B+CD+PWD where CD would represent (CD or PD)

Abdominal includes renal, GYN/Pelvio

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mum S. Phatl
(Division Sign-Off)

Office of In

510K K110202

CONFIDENTIAL

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

Page 52 of 1519

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

510(k) Number (If Known):

System Name: Transducer: FZT C9-3 (Curvilinear Probe)

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

| Clinical Application | | Mode of Operation | | | | | | Other |
|------------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler2 | Combined3 | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal4 | N | N | N | | N | N | |
| General<br>Application | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | |
| | Other (Specify) | | | | | | | |

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

Includes B-Mode and Harmonic Imaging (HI)

Includes Color Doppler (CD) and Power Doppler (PD)

Includes B+M, B+CD+PWD where CD would represent (CD or PD)

Abdominal includes renal, GYN/Pelvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Postel
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safe:

510K K110202

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(K) Submission

Page 53 of 1519

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

510(k) Number (If Known):

FUJIFILM Diagnostic Ultrasound System FAZONE CB System Name: Transducer: FZT L14-5sp (Linear Probe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|------------------------------------------------|-------------------|---|-----|-----|----------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color Doppler2 | Combined3 | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal4 | N | N | N | | N | N | |
| General Application | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | N | N | N | | N | N | |
| | Neonatal Cephalic | N | N | N | | N | N | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | |
| | Other (Specify) | | | | | | | |

E = added under this appendix viously cleared by FDA;

Includes B-Mode and Harmonic Imaging (HJ)

2 Includes Color Doppler (CD) and Power Doppler (PD)

Includes B+M, B+CD+PWD where CD would represent (CD or PD)

Abdominal includes renal, GYN/Pelvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mury S. Padat
Division Sign-Off

Office of in Vitro Diagn

510K K110202

CONFIDENTIAL

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

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

510(k) Number (If Known):

FUJIFILM Diagnostic Ultrasound System FAZONE CB System Name:

Transducer: FZTL14-5w (Linear Probe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|------------------------|------------------------------------------------|-------------------|---|-----|-----|-------------------|-----------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler2 | Combined3 | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | |
| | Abdominal4 | N | N | N | | N | N | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | |
| | Small Organ<br>(Thyroid, Breast, Testes, etc.) | N | N | N | | N | N | |
| | Neonatal Cephalic | N | N | N | | N | N | |
| General<br>Application | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Tran-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Tran-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | |
| | Other (Specify) | | | | | | | |

E = added under this appendix Cleared by FDA,

Includes B-Mode and Harmonic Imaging (H1)

Includes Color Doppler (CD) and Power Doppler (PD)

Includes B+M, B+CD+PWD where CD would represent (CD or PD)

Abdomina! includes renal, GYN/Petvic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Post
(Division Sign-Off)

510K K110202

CONFIDENTIAL

FUJIFILM Diagnostic Ultrasound System FAZONE CB 510(k) Submission

Page 55 of 1519