BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM

K030455 · Philips Ultrasound, Inc. · IYN · Mar 13, 2003 · Radiology

Device Facts

• Record ID: K030455
• Device Name: BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: Mar 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Boris Platform system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body. The clinical applications include: ophthalmic, fetal, abdominal, intra-operative, laparoscopic, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, transesophageal, peripheral vessel and cerebral vascular applications.

Device Story

Boris Platform is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via piezoelectric transducers (phased, linear, curved arrays, TEE, pencil probes) and displays images in modes including 2D, M-mode, Color Doppler, Color Power Angio, CW Doppler, and Tissue Doppler. Operated by healthcare professionals in clinical settings, the system provides anatomical measurements and analysis packages to assist in diagnosis. Data is stored locally or via network/DVD in industry-standard formats (DICOM, JPEG, AVI). The system includes secure access tools for HIPAA compliance. Clinicians use the output for real-time visualization, biopsy guidance, and monitoring of cardiac/vascular function, aiding in clinical decision-making and patient management.

Clinical Evidence

Bench testing only. The device was evaluated against safety standards including IEC 60601-1, UL 2601-1, and NEMA UD 2/3 for acoustic output. No clinical data was required for this 510(k) submission.

Technological Characteristics

Mobile ultrasound system using piezoelectric transducer technology. Supports phased, linear, curved, TEE, and pencil arrays. Modes: 2D, M-mode, Color Doppler, Color Power Angio, CW/PW Doppler, Tissue Doppler. Connectivity: Network/DVD (DICOM, JPEG, AVI). Standards: IEC 60601-1, UL 2601-1, NEMA UD 2/3. Software-controlled with touch panel and alphanumeric keyboard interface.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients across all ages (neonatal to adult) for clinical applications including ophthalmic, fetal, abdominal, intra-operative, laparoscopic, pediatric, small organ, cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, transesophageal, and vascular studies.

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

• Philips HDI® 5000 ultrasound system (K961459, K991671, K002003)

Submission Summary (Full Text)

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### MAR 1 3 2003 510(k) Summary of Safety and Effectiveness

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

### 1) Submitter's name, address, telephone number, contact person

Lynn Harmer Manager Regulatory Submissions Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431 Telephone: [phone] Facsimile: [phone] E-mail: [e-mail]

Date prepared: 16 January 2003

## 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

| Common/Usual Name: | Diagnostic ultrasound system with accessories |
|--------------------|-----------------------------------------------|
| Proprietary Name: | Boris Platform Diagnostic Ultrasound System |

| Classification Name | Federal Regulations<br>Number | Product Code |
|------------------------------------------|-------------------------------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasonic Transducer | 892.1570 | 90-ITX |

### 3) Substantially Equivalent Devices

Philips Ultrasound believes that the Boris Platform system and transducers are substantially equivalent to the currently marketed Philips HDI® 5000 ultrasound system and transducers cleared in K961459, K991671, and K002003.

## 3) Device Description

The Boris system is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.

The device consists of two parts: the system console and the transducer. The system console contains the user interface, a display, system electronics and optional peripherals (printers, VCR). In addition to the physical knobs and buttons of the main control panel,

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the user interface consists of a Touch Panel, to access additional less-frequently-used controls, and the Alphanumeric Keyboard to enter patient data and other text.

The removable transducers are connected to the system using standard technology. The Boris system uses standard transducer technology, and supports phased, linear, and curved linear arrays, TEE, motorized 3D curved linear arrays as well as Non-Imaging (Pencil) probes.

The Boris system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

Clinical data storage consists of a local repository as well as off-line image storage via the network or DVD. The images are stored in industry-standard formats (Ex. JPEG. A VI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA.

The Boris Platform system has been designed to meet the following standards:

- IEC 60601-1 ●
- UL 2601-1 ●
- C22.2 No. 601.1 ●
- IEC 60601-1-2 ●
- . IEC 60601-2-37
- . NEMA UD 2 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
- . NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

## 4) Intended Use

The Boris Platform system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body. The clinical applications include: ophthalmic, fetal, abdominal, intra-operative, laparoscopic, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, transesophageal, peripheral vessel and cerebral vascular applications.

Typical examinations using the Boris Platform system include:

- General abdominal and pelvic studies including organ surveys, blood flow . assessment, and retroperitoneal cavity studies.
- . Study of small parts and superficial structures including breasts, shoulders, thyroid, and testicles.
- . Pediatric scans of organs, superficial, and bony structures.
- . Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile arterv.
- Monitoring procedures for infertility studies (other than in vitro fertilization.) .

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- First, second, and third trimester pregnancy studies. .
- Prostate, prostate biopsy guidance, and rectal wall studies. .
- . Neonatal head studies.
- Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral . arteries.
- Cardiac studies in adults and children. ●
- Monitoring of cardiac function during procedures using transesophageal . echocardiography.
- Biopsy guidance for tissue or fluid sampling. ●
- Assessment of cardiac muscle, coronary arteries and great vessels during cardiac . surgery.
- Study of myocardial function in adults ●
- Study of eye anatomy including blood flow in retinal vessels and branches. ●
- Study of esophagus, stomach, biliary system, pancreas and gastrointestinal tract using . endoscopic probe.
- . Study of abdominal and pelvic organs and masses using laparoscopic probe.
- Examination of organs, masses and vessels during surgical procedures. ●
- Study of muscles, ligaments, nerve bundles and connective tissue. .

### 5) Technical Characteristics

This device operates identically to the predicate device in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D and M-mode images. Doppler shift caused by blood flow or tissue is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, M-mode, Color Doppler, Color M-Mode, Color Power Angio, CW Doppler, Tissue Doppler Imaging, Pulsed Tissue Doppler, and Pulsed Doppler) are the same as the predicate device.

### 6) Conclusion

The Boris Platform ultrasound system and transducers are substantially equivalent in safety and effectiveness to the HDI 5000 system and transducers.

- Both systems are intended for diagnostic ultrasound imaging and fluid flow analysis. .
- Both systems use essentially the same technologies for imaging, Doppler functions . and signal processing.
- Both systems have acoustic output levels below the applicable FDA limits.
- Both systems are manufactured of materials with materials that have been evaluated . and found to be safe for its application.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three swooping lines representing its wings. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 3 2003

Philips Ultrasound, Inc. % Ms. Laura Danielson 510(k) Program Manager TUV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K030455

Trade Name: Boris Platform 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: 90 IYN, IYO, and ITX Dated: February 28, 2003 Received: March 3, 2003

### Dear Ms. Danielson:

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 Boris Platform Ultrasound System, as described in your premarket notification:

Transducer Model Number

C5-2 / 5.0-2.0 MHz / 40mm Curved Array C8-4v / 8.0-4.0 MHz / 11mm / Curved Array C8-5 / 8.0-5.0 MHz / 14mm Curved Array

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C9-4 / 4.0-9.0 MHz / 40mm Curved Array C9-5ec / 9.0-5.0 MHz / 8mm / Curved Array D2 CW / 2.0 MHz / Static Probe D2 TC / 2.25 MHz / Static Probe L8-4 / 8.0-4.0 MHz / 38mm / Linear Array L9-5 -LAP / 9.0-5.0 MHz / 28mm / Laparascopic Linear Array L12-5 / 12.0-5.0 MHz / 50mm / Linear Array L15-7 i.o. / 15-7.0 MHz / 38mm / Linear Array L17-5 / 5.0-17.0 MHz / 39mm Linear Array S3-1 / 1.0-3.0 MHz / Phased Array S4-1 / 4.0-1.0 MHz / Phased Array S6-2t Trans-Esophageal (Adult) 2.0-6.0 MHz / 9mm / motorized phased x-Matrix Multi-Dimensional Phased Array 3D IVT / 7.5 MHz / 11.5mm Motorized 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 (OS) 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, vou 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

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Page 3 - Ms. Danielson

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy C. Brogdon

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

Enclosure(s)

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### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System: Transducer: Intended Use:

#### Boris Platform 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 | N | N | N | N | N | Notes 1, 3 | Notes 5, 6, 8,10,12, 13 |
| Fetal Imaging<br>& Other | Fetal | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 7, 8, 10,<br>12, 13 |
| | Abdominal | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 7, 8, 10,<br>11, 12, 13 |
| | Intra-operative<br>(Abdominal, Spine, Vascular) | N | N | N | N | N | Notes 1, 3 | Notes 5, 6, 8,10,12, 13 |
| | Intra-operative (Neuro.) | N | N | N | N | N | Notes 1, 3 | Notes 3, 5, 6, 10, 12,<br>13 |
| | Laparoscopic | N | N | N | N | N | Notes 1, 3 | Notes 8, 10, 12, 13 |
| | Pediatric | N | N | N | N | N | Notes 1, 2, 3 | Note 5, 6, 8, 9, 10, 12,<br>13 |
| | Small Organ (breast, thyroid,<br>testicle) | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 8, 10, 11,<br>12, 13 |
| | Neonatal Cephalic | N | N | N | N | N | Notes 1, 3 | Notes 5, 8, 10, 12, 13 |
| | Adult Cephalic | N | N | N | N | N | Notes 1, 3, 4 | Notes 10, 13 |
| | Trans-rectal | N | N | N | N | N | Notes 1, 3 | Notes 5, 6, 10, 12, 13 |
| | Trans-vaginal | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 10, 12, |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 8,10, 12,13 |
| | Musculo-skel. (Superficial) | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 8, 10,<br>12,13 |
| | Intra-luminal | | | | | | | |
| | Other: Urology | N | N | N | N | N | Notes 1, 3 | Notes 5, 10, 12 |
| Cardiac | Cardiac Adult | N | N | N | N | N | Notes 1,2,3,4 | Notes 10, 13 |
| | Cardiac Pediatric | N | N | N | N | N | Notes 1,2,3,4 | Notes 10, 11, 13 |
| | Trans-esophageal (Cardiac) | N | N | N | N | N | Notes 1,2,3,4 | Note 10 |
| | Other (Fetal Echo) | N | N | N | N | N | Notes 1,2,3,4 | Notes 10, 12, 13 |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Notes 1, 2, 3 | Notes 2, 3, 5, 6, 7, 8,<br>10, 12, 13 |
| | Cerebral Vascular | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 8, 10, 12,<br>13 |

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

Additional Comments: *Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 7. Infortility mornity of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Nancy C. Ingdon

0
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030455

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### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System:

Boris Platform Ultrasound System

Transducer: Intended Use: C5-2 / 5.0 - 2.0 MHz / 40mm Curved Array

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 | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 7, 8, 10,<br>12 |
| | Abdominal | N | N | N | | N | Notes 1, 3 | Notes 5, 6, 8. 10, 12 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Notes 1, 3 | Notes 5, 6, 8, 9, 10,<br>12 |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other: Urology | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | Note 1 | Notes 2, 3, 5, 7 |
| | Other (Specify) | | | | | | | |

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

Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

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

Nancy C Hopton

(Divis and f 510(k) Numb

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#### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System:

・

Boris Platform Ultrasound System

- Transducer: Intended Use:
C8-4v / 8.0-4.0 MHz / 11mm / Curved Array

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 | N | N | N | | N | Notes 1, 3 | Notes 5, 6, 10, 12 |
| | Abdominal | N | N | N | | N | Notes 1, 2, 3 | Notes 5,6,7,10,12 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | N | N | N | | N | Notes 1, 2, 3 | Notes 5, 6, 10, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Urology | N | N | N | | N | Notes 1, 3 | Notes 5, 10, 12 |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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

*Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Narryl Brogdon

(Division Division o and Ra 510(k) Number

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510(k) Number: System: Transducer: Intended Use:

Boris Platform Ultrasound System

C8-5 / 8.0-5.0 MHz / 14mm Curved Array

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 | N | N | N | N | N | Notes 1, 3 | Notes 5, 8, 10,<br>12, 13 |
| | Abdominal | N | N | N | N | N | Notes 1, 3 | Notes 5, 7, 8, 10<br>12, 13 |
| | Intra-operative<br>(Abdominal, vascular) | | | | | | | |
| | Intra-operative (Neuro.) | N | N | N | N | N | Notes 1, 3 | Notes 3, 5, 6, 10,<br>12, 13 |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Notes 1, 3 | Notes 5, 8, 10,<br>12, 13 |
| | Small Organ | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | Notes 1, 3 | Notes 5, 8, 10,<br>12, 13 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Notes 1, 3, | Notes 5, 8, 10, 12 |
| | Cerebral Vascular | N | N | N | N | N | Notes 1, 3 | Notes 5, 8, 10, 12 |

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

*Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

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

Nancy C. Burgdon

(Division Sign-Off Division of Reproductiv and Radiological Devices 510(k) Number

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### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System: Transducer:

#### Boris Platform Ultrasound System

Intended Use:

C9-4/4.0-9.0 MHz/ 40 mm Curved Array

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 Imaging<br>& Other | Fetal | N | N | N | | N | Notes 1, 3 | Notes 5, 6, 8, 10, 12, 13 |
| | Abdominal | N | N | N | | N | Notes 1, 3 | Notes 5, 6, 7, 8, 10, 12, 13 |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Notes 1, 3 | Notes 5, 6, 8, 10, 12, 13 |
| | Small Organ | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Cerebral Vascular | | | | | | | |

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

*Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Marvey C. Higdon

Divisi and Radiolo 510(k) Number

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

510(k) Number: System:

Boris Platform Ultrasound System

Transducer: Intended Use: C9-5ec / 9.0-5.0 MHz / 8mm / Curved Array

loo: Diagnostic ultrasound imaging or fl

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 | N | N | N | | N | Notes 1, 3 | Notes 5, 10, 12, |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | Notes 1, 3 | Notes 5, 6, 10,<br>12, 13 |
| | Trans-vaginal | N | N | N | | N | Notes 1, 2, 3 | Notes 5, 6, 10, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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

Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

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

Nancy Shogton

(Division Si Division of Abdomi and Radiological Devices 510(k) Number

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

#### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System: Transducer:

Boris Platform Ultrasound System

D2 CW / 2.0 MHz / Static Probe

Intended Use:

Bone Phantom Simulated Density
D2 CW / 2.0 MHz / Static Probe

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 Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal<br>Intra-operative<br>Intra-operative (Neuro.)<br>Laparoscopic<br>Pediatric<br>Small Organ<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Trans-urethral<br>Trans-esoph. (non-Cardiac)<br>Musculo-skel. (Conventional)<br>Musculo-skel. (Superficial)<br>Intra-luminal<br>Other | | | | | | | |
| Cardiac | Cardiac Adult | | | | N | | | |
| | Cardiac Pediatric | | | | N | | | |
| | Trans-esophageal (Cardiac)<br>Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel<br>Other | | | | | | | |

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

*Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Darcy C. Brogdon
(Division Sign-Off)

Divis and Radiolo 510(k) Number

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

### DIAGNOSTIC UTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System:

Boris Platform Ultrasound System

Transducer:

D2 TC / 2.25MHz Static Probe

Intended Use:

D2 TO 7 2:25MHz Otatio Frobo
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 Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | N | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other | | | | | | | |

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

*Color Doppler includes Color Amplitude Doppler

Note 1 : Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

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

Nancy Hogdon

and Rac 510(k) Numbe

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

510(k) Number: System: Transducer:

Boris Platform Ultrasound System

Intended Use:

L8-4 / 8.0-4.0 MHz / 38mm / Linear Array

Diagnostic uttrasound 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 | | | | | | | |
| | Abdominal | N | N | N | N | N | Notes 1, 3 | Notes 5, 6, 8, 10,<br>12, 13 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Notes 1, 3 | Notes 5, 6, 8, 10,<br>12, 13 |
| | Small Organ (Breast) | N | N | N | N | N | Notes 1, 3 | Notes 5, 6, 8, 10,<br>11, 12, 13 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 8, 10,<br>12, 13 |
| | Musculo-skel. (Superficial) | N | N | N | N | N | Notes1, 2, 3 | Notes 5, 6, 8, 10,<br>12, 13 |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 8, 10,<br>12, 13 |
| Vessel | Cerebral Vascular | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 8, 10,<br>12, 13 |

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

Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 2: Gombined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for quidance of biopsy

Note 7: Infertility monitoring of foilicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Marcy Burgdorf

(Divis Div and B 510(k) Nur

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

510(k) Number: System: Transducer: Intended Use:

Boris Platform Ultrasound System

L9-5 -LAP / 9.0 -- 5.0 MHz / 28mm / Laparascopic Linear Array

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

| | | | 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 Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (abdomen) | N | N | N | | N | Notes 1, 3 | Notes 8, 10, 12,<br>13 |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | N | N | N | | N | Notes 1, 3 | Notes 8, 10, 12,<br>13 |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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

Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Solor Doppined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Nancy Brogdon

and Radiologic 510(k) Numbe

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

510(k) Number: System: Transducer: Intended Use:

#### Boris Platform Ultrasound System

L12-5 / 12.0 - 5.0 MHz / 50mm / Linear Array

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 | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 8, 10, 12, 13 |
| | Abdominal | N | N | N | N | N | Notes 1, 2, 3 | Notes 5, 6, 8, 10, 11, 12, 13 |
| | Intra-operative | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric…