Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard diagnostic ultrasound system with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The description focuses on traditional ultrasound technology and data handling.

Therapeutic

No
The device is strictly described as a "diagnostic ultrasound imaging" system, and its intended use is to "acquire ultrasound data and to display the data in various modes of operation" to aid in diagnosis, not treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The Boris Platform system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body." The "Device Description" also refers to it as a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of two parts: the system console and the transducer. These are hardware components, making it a hardware and software system, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis. The Boris system is an ultrasound imaging system that examines the human body in vivo (inside the body) using sound waves.
The intended use and device description clearly state that the system is for diagnostic ultrasound imaging and fluid flow analysis of the human body. This is a form of medical imaging, not in vitro testing.
The device description focuses on the hardware (console, transducers), software control, and imaging capabilities. There is no mention of analyzing biological specimens or using reagents.

Therefore, the Boris Platform system falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.) .
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. .

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

90-IYN, 90-IYO, 90-ITX

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, 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

No

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Abdominal, Intra-operative, Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac (Adult, Pediatric, Trans-esophageal, Fetal Echo), Peripheral vessel, Cerebral Vascular.

Indicated Patient Age Range

Neonatal, pediatric, adult

Intended User / Care Setting

Competent health care professionals

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

Not Found

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

Not Found

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

Not Found

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

Not Found

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

K961459, K991671, K002003

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

Not Found

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

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: (425) 487-7312 Facsimile: (425) 487-8666 E-mail: Lynn.Harmer@Philips.com

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
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,

1

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.) .

2

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.

3

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

4

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

5

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.

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)

6

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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8,10,12, 13
Fetal Imaging
& Other	Fetal	N	N	N	N	N	Notes 1, 2, 3	Notes 5, 6, 7, 8, 10,
12, 13
	Abdominal	N	N	N	N	N	Notes 1, 2, 3	Notes 5, 6, 7, 8, 10,
11, 12, 13
	Intra-operative
(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,
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,
13
	Small Organ (breast, thyroid,
testicle)	N	N	N	N	N	Notes 1, 2, 3	Notes 5, 6, 8, 10, 11,
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,
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
Vessel	Peripheral vessel	N	N	N	N	N	Notes 1, 2, 3	Notes 2, 3, 5, 6, 7, 8,
10, 12, 13
	Cerebral Vascular	N	N	N	N	N	Notes 1, 2, 3	Notes 5, 6, 8, 10, 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 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

7

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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	Notes 1, 2, 3	Notes 5, 6, 7, 8, 10,
12
	Abdominal	N	N	N		N	Notes 1, 3	Notes 5, 6, 8. 10, 12
	Intra-operative (Specify)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Notes 1, 3	Notes 5, 6, 8, 9, 10,
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
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

8

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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(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
& 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
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

9

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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	Notes 1, 3	Notes 5, 8, 10,
12, 13
	Abdominal	N	N	N	N	N	Notes 1, 3	Notes 5, 7, 8, 10
12, 13
	Intra-operative
(Abdominal, vascular)
	Intra-operative (Neuro.)	N	N	N	N	N	Notes 1, 3	Notes 3, 5, 6, 10,
12, 13
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Notes 1, 3	Notes 5, 8, 10,
12, 13
	Small Organ
	Neonatal Cephalic	N	N	N	N	N	Notes 1, 3	Notes 5, 8, 10,
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
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

10

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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& 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
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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	Notes 1, 3	Notes 5, 10, 12,
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	Notes 1, 3	Notes 5, 6, 10,
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
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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
Intra-operative
Intra-operative (Neuro.)
Laparoscopic
Pediatric
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
Cardiac	Cardiac Adult				N
	Cardiac Pediatric				N
	Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
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

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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& 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
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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10,
12, 13
	Intra-operative (Specify)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10,
12, 13
	Small Organ (Breast)	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10,
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,
12, 13
	Musculo-skel. (Superficial)	N	N	N	N	N	Notes1, 2, 3	Notes 5, 6, 8, 10,
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,
12, 13
Vessel	Cerebral Vascular	N	N	N	N	N	Notes 1, 2, 3	Notes 5, 6, 8, 10,
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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (abdomen)	N	N	N		N	Notes 1, 3	Notes 8, 10, 12,
13
	Intra-operative (Neuro.)
	Laparoscopic	N	N	N		N	Notes 1, 3	Notes 8, 10, 12,
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
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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(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
& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Notes 1, 2, 3	Notes 5, 6, 8, 10, 12, 13
	Small Organ (Breast,
thyroid, testicle)	N	N	N	N	N	Notes1, 2, 3	Notes 5, 6, 8, 10, 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, 3	Notes 5, 6, 8, 10, 12, 13
	Musculo-skel. (Superficial)	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10, 12, 13
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	Notes 1,2, 3	Notes 5, 6, 8, 10, 12, 13
	Cerebral Vascular	N	N	N	N	N	Notes 1, 2, 3	Notes 5, 6, 8, 10, 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 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

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

17

510(k) Number: System: Transducer: Intended Use:
Boris Platform Ultrasound System

Lons / lation / 15 - 7.0 MHz / 38mm / 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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	N	N	N		N	Notes 1, 3	Notes 5, 8, 10,
12, 13
	Fetal
	Abdominal
	Intra-operative
(Spine, Vascular)	N	N	N		N	Notes 1, 3	Notes 5, 8, 10, 12
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast)	N	N	N		N	Notes 1, 3	Notes 5, 8, 10,
12, 13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	N	N	N		N	Notes 1,3	Notes 5, 8, 10,
12, 13
	Musculo-skel. (Superficial)	N	N	N		N	Notes 1,3	Notes 5, 8, 10, 12
,13
	Intra-luminal
	Other
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other
(Coronary Artery)
Peripheral	Peripheral vessel	N	N	N		N	Notes 1, 3	Notes 5, 8, 10,
12, 13
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

Nancy C Hogdon

. : : : : : and Radiol 510(k) Number

18

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System: Transducer: Intended Use:
Boris Platform Ultrasound Systern

L17-5 / 5.0-17.0 MHz /39 -mm Linear Array

ETF-S7 550-177.0 KHz 100 million analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10,
12, 13
Fetal Imaging
& Other	Fetal	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10,
12, 13
	Abdominal	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 7, 8,
10, 12, 13
	Intra-operative
(Abdominal, vascular)	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10,
12, 13
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10,
12, 13
	Small Organ (breast, thyroid, testicle)	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10,
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, 3	Notes 5, 6, 8, 10,
12, 13
	Musculo-skel. (Superficial)	N	N	N	N	N	Notes 1, 3	Notes 5, 6, 8, 10,
12, 13
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	Note 1, 3	Note 5, 6, 8, 10,
12, 13
	Cerebral Vascular	N	N	N	N	N	Note 1, 3	Note 5, 6, 8, 10,
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 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 Broadon

and Radio 510(k) Number

Section 4.3

Page 13

19

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

Boris Platform Ultrasound System

S3-1 / 1.0-3.0 MHz /Phased Array

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	Notes 1, 3, 4	Notes 10, 13
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
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)
	Fetal Echo	N	N	N	N	N	Notes 1, 2, 3, 4	Notes 10, 13
Peripheral
Vessel	Peripheral vessel

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

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproduc and Radiological Devices 510(k) Number

20

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

Boris Platform Ultrasound System

S4-1 / 4.0 -- 1.0 MHz / Phased Array

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	Notes 1, 2, 3	Notes 10, 12, 13
	Abdominal	N	N	N		N	Notes 1, 3	Notes 10, 11,
12, 13
	Intra-operative
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Specify)
Peripheral
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 imaning
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. Brogdon

and R 510(k) Num

21

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

Boris Platform Ultrasound System

ucer: S6-2t Trans-E
led Use: Diagnostic ultra

S6-2t Trans-Esophageal (Adult) 2.0-6.0 MHz/ 9 mm/ motorized phased Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spac.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative
	Intra-operative (Neuro.)
	Laparoscopic
	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)	N	N	N	N	N	Notes 1, 2,
3, 4	Note 10
	Other (Specify)
Peripheral
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 quidance of biopsy

Note 7: Infertility monitoring of follicie development

Note 8: Extended Fleid of Vlew (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 Brogdon

Division S Divis and F 510(k) Nun

Section 4.3

_ا

22

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

Boris Platform Ultrasound System

X-Matrix Multi-Dimensional Phased Array

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	Notes 1, 2, 3	Notes 10, 12, 13
	Abdominal	N	N	N		N	Notes 1, 3	Notes 10, 11, 12,
13
	Intra-operative
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	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
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

Nancy C hogdon

and Ra 510(k) Num

23

510{k} Number: System: Transducer: Intended Use:
Boris Platform Ultrasound System

3D IVT /7.5 MHz /11.5 mm Motorized 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
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N		N	Notes 1, 3	Notes 5, 10, 12, 13
	Abdominal	N	N	N		N	Notes 1,3	Notes 5, 10, 12, 13
	Intra-operative
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	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)
	Fetal Echo	N	N	N		N	Notes 1, 2, 3	Note 12
Peripheral
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

Nancyc broglon

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