ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202

• K Number: K081154
• Device Name: ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
• Manufacturer: B-K MEDICAL APS
• Date Cleared: 2008-05-23 ( 30 days)
• Product Code: IYO ITX IYN
• Regulation Number: 892.1560

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.

Device Description

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

Predicate Devices

K043524

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ultrasound modes, measurements, and 3D reconstruction, with no mention of AI or ML terms or capabilities.

Therapeutic

No
The device is described for "Diagnostic ultrasound imaging or fluid flow analysis", without any mention of therapeutic functions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The device also performs measurements and calculations for various medical applications, which are characteristic of diagnostic devices.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components and scanning modes associated with a physical ultrasound system, not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• This device is an ultrasound scanner. Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It directly examines the human body, not specimens taken from it.
• The intended use and device description clearly state its function is diagnostic ultrasound imaging and fluid flow analysis of the human body. This involves real-time imaging and measurement within the body.

Therefore, the Flex Focus 1202, as described, falls under the category of medical imaging devices, not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

For System 1202, all transducers:
Clinical Application: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.
Modes of Operation: B, M, PWD, CFM (Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler) and combinations. Tissue harmonic imaging.
Combined modes: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Doppler). Fetal is often called Obstetrics.

For Transducer 1850 (with interchangeable probes 8539, 6004, 6005):
Specific (Tracks I & III) applications: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Specify), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Conventions), Musculo-skel. (Superficial), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel.
Modes of Operation: B, M, PWD, CWD, Color Doppler, Combined (Specify), Other* (Specify).
Combined (Specify): B+M, B+D, B+C, B+D+C.
Other* (Specify): Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
Additional Comments: Intraoperative: Rectum, Urethra, Urinary bladder,

For Transducer 8661:
Specific (Tracks I & III) applications: Fetal, Trans-vaginal.
Modes of Operation: B, M, PWD, Color Doppler, Combined, Amplitude Doppler.
Combined Modes: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler).

For Transducer 8662:
Specific (Tracks I & III) applications: Intra-operative (Specify 2), Intra-operative (Neuro), Pediatric.
Modes of Operation: B, M, PWD, Color Doppler, Combined (Specify 1), Amplitude Doppler.
Combined (Specify 1): B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler).
Additional Comments: 2)Intraoperative: Gall bladder

For Transducer 8811:
Specific (Tracks I & III) applications: Intra-operative (Specify 2), Pediatric, Small Organ (Specify 3), Musculo-skel. (Conditional), Musculo-skel. (Superficial), Peripheral vessel.
Modes of Operation: B, M, PWD, Harmonic imaging, Color Doppler, Combined (Specify 1), Amplitude Doppler.
Combined (Specify 1): B, B+M, B+C, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler).
Additional Comments: 2)Intraoperative: Breast, liver, pancreas, billiary system. 3)Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes.

For Transducer 8820e:
Specific (Tracks I & III) applications: Fetal 2), Abdominal 2).
Modes of Operation: B, M, PWD, Color Doppler, Combined (Specify), Amplitude Doppler.
Combined (Specify): B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler).
Additional Comments: 2) includes obstetrics

For Transducer 8000:
Specific (Tracks I & III) applications: Cardiac Adult.
Modes of Operation: B, M, PWD, Color Doppler, Combined (Specify), Amplitude Doppler.
Combined (Specify) 1): B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler).

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

IYN, IYO and ITX

Device Description

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Cardiac, Fetal, Intraoperative (Rectum, Urethra, Urinary bladder, Gall bladder, Breast, liver, pancreas, billiary system), Transurethral, Neurosurgery, Transrectal, Small Parts (organs, Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes), Transvaginal, Peripheral vascular, Musculo-skeletal.

Indicated Patient Age Range

Fetal, Pediatric, Adult

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

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

K043524

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

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

510(k) Summary:

K081154

MAY 2 3 2008

This summary is provided as part of this Premarket Notification in compliance with 2 Section 807.92.

Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: [phone] Fax: [phone] Contact person: Jens Rasmussen, Director of Quality Date prepared: 17 April, 2008

Trade name: Ultrasound Scanner Flex Focus 1202 Common name: Diagnostic Ultrasound System Classification names: Ultrasonic Pulsed Echo Imaging System (90 IYO, CFR 892.1560) Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1560) (90 ITX, CFR 892.1570) Diagnostic Ultrasonic Transducer

Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Pro Focus 2202, K043524

Device description:

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.

The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.

The system can guide biopsy- and puncture needles.

An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

Transducers

Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Flex Focus 1202 are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in Flex Focus 1202 is the same as the system in Pro Focus 2200. The system will assure that the acoustic output always will stay below the preamendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0

Clinical measurement accuracy.

Clinical measurements and calculations are described and accuracies are provided in the User Guide.

Thermal, mechanical and electrical safety.

The scanner Flex Focus 1202 has been tested by a recognized Certified Body.

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Image /page/1/Picture/0 description: The image shows handwritten text. The text at the top reads "KO 81154". Below that, the text reads "pg. 2 of 2".

Acoustic Output Reporting

The Acoustic Output Reporting is made according to the standards required by "Inf Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997"

Intended use.

1202 intended uses are contained within 2202-intended uses:

| | Cleared, unmodified device,
Ultrasound scanner Pro Focus 2202,
K043524 | Modified device, Ultrasound scanner Flex Focus 1202 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modes of operation | B, M, PWD, CFM 1) and
combinations.
Tissue harmonic and contrast
harmonic imaging | B, M, PWD,CFM 1) and
combinations.
Tissue harmonic imaging |
| Intended use(clinical application) | Abdominal
Cardiac
Fetal (incl Obstetrics)
Intraoperative
Transurethral
Neurosurgery
Pediatrics
Transrectal
Small Parts (organs)
Transvaginal
Peripheral vascular
Musculo-skeletal | Abdominal
Cardiac
Fetal (incl Obstetrics)
Intraoperative
Transurethral
Neurosurgery
Pediatrics
Transrectal
Small Parts (organs)
Transvaginal
Peripheral vascular
Musculo-skeletal |

1. CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler.

Technological characteristics compared to the predicate device.

The predicate device has the same major technological characteristics as the subject device described above.

Minor differences consist: Modified scanconverter, modified transmitter, modified beamformer, modified mechanical outline.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, arranged in a cascading manner.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

· MAY 2 3 2008

Mr. Jens Rasmussen Director of Quality B-K Medical ApS Mileparken 34, DK 2730 Herlev DENMARK

Re: K081154

Trade/Device Name: Ultrasound Scanner Flex Focus 1202 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN. IYO and ITX Dated: April 17, 2008 Received: April 23, 2008

Dear Mr. Rasmussen:

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 Ultrasound Scanner Flex Focus 1202, as described in your premarket notification:

Transducer Model Number

1850 (with interchangeable probes 8539, 6004, 6005)

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

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

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

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). · You may obtain

other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

4

Page 3 - Mr. Rasmussen

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

Sincerely yours,

Vopu M Whang

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

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Enclosure(s)

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5

Diagnostic Ultrasound Indications for Use Form

System: 1202

Fill out one form for each ultrasound system and each transducer.

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

	Mode of Operation
Clinical Application	A	B	M	PWD	Tissue-
harmonic
imaging	Color
Doppl
er	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify 1)	Continous
Wave)
Ophthalmic
Fetal		P	P	P	P	P	P		P
Abdominal		P	P	P	P	P	P		P
Intraoperative (specify)		P	P	P	P	P	P		P
Intraoperative Neurological		P	P	P	P	P	P		P
Pediatric		P	P	P	P	P	P		P
Small Organ (specify)		P	P	P	P	P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal		P	P	P	P	P	P		P
Transvaginal		P	P	P	P	P	P		P
Transurethral		P	P	P	P	P	P		P
Intravascular
Peripheral Vascular		P	P	P	P	P	P		P
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P		P
Musculo-skeletal Superficial		P	P	P	P	P	P		P
Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: 1} B+M, B+D, B+C, B+D+C.
							D is PWD, C is Color Doppler. Fetal is often called Obstetrics

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

tony m. Pham

uctive. Abdominal and

6

1202 System: 1850_(with interchangeable probes_8539,6004,6005) Transducer:

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

Clinical Application		Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	P
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging
& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P
	Trans-vaginal
	Trans-urethral	P
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

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

*Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

Additional Comments: Intraoperative: Rectum, Urethra, Urinary bladder,

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Tony M. Whg

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

7

System:	1202
Transducer:	8661

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

Clinical Application		Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Amplitude
Doppler
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	P 1)	P
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	P 1)	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

B+M, B+D, B+C, B+D+C. (D is PWD, C is Additional Comments:_ _1))Mode combinations: Color Flow mapping Doppler including Amplitude(power)Doppler) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Lona Th. Witz

(Divis ductive. Abdomina Division of Re Radiological Devices 510(k) Number

8

1202_ System: 8662 Transducer:

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

Clinical Application		Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color Doppler	Combined
(Specify 1)	Amplitude
Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify 2)	P	P	P		P	P	P
	Intra-operative (Neuro)	P	P	P		P	P	P
	Laparoscopic
Fetal Imaging
& Other	Pediatric	P	P	P		P	P	P
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

1. Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow Additional Comments: mapping Doppler including Amplitude(power)Doppler)_ 2)Intraoperative: Gall bladder

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Lorge 7. Whz

(Division Sin Division of Reproductive, Abdominal Radiological Device 510(k) Number

9

_1202 System: 8811 Transducer:

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

Clinical Application		Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	Harm
onic
imagin
g	Color
Doppler	Combined
(Specify 1)	Amplitude
Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify 2)	P	P	P	P	P	P	P
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging
& Other	Pediatric	P	P	P	P	P	P	P
	Small Organ (Specify 3)	P	P	P	P	P	P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)	P	P	P	P	P	P	P
	Musculo-skel. (Superficial)	P	P	P	P	P	P	P
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (Specify)

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

*Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

Additional Comments: 2)Intraoperative: Breast, liver, pancreas, billiary system

3)Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes 1)mode combinations: B, B+M, B+C, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Lorry M. Witz

(Division/S

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1202__________________________________________________________________________________________________________________________________________________________________________ System: 8820e Transducer:

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

Clinical Application		Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Amplitude
Doppler
Ophthalmic	Ophthalmic
	Fetal 2)	P	P	P		P	P 1)	P
	Abdominal 2)	P	P	P		P	P 1)	P
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging
& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

1))Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Additional Comments:_ Color Flow mapping Doppler including Amplitude(power)Doppler)_ 2) includes obstetrics

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Aorgue Th. Wtz

ductive. Abdomin 510(k) N

11

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

Clinical Application		Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Amplitude
Doppler
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P		P	P 1)	P
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

B+M, B+D, B+C, B+D+C. (D is PWD, C is Additional Comments:__________________________________________________________________________________________________________________________________________________________ 1))Mode combinations: Color Flow mapping Doppler including Amplitude(power)Doppler)

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

hospitn 22

(Division Division of Reproductive, Abdominal a Radiological De 510(k) Number