Predicate Devices

K024236 (JAN17 2003)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound imaging modes, measurements, and 3D reconstruction, without mentioning any AI/ML-specific features or performance metrics. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No
The "Intended Use" clearly states "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

No

The device description explicitly mentions "Transducers are linear and convex arrays and mechanical sector," which are hardware components of an ultrasound system, indicating it is not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use describes diagnostic ultrasound imaging and fluid flow analysis of the human body. This is an in-vivo (within the living body) diagnostic method.
Device Description: The description details an ultrasound system that performs imaging and measurements directly on the patient.
Lack of IVD Characteristics: There is no mention of analyzing samples taken from the human body (like blood, urine, tissue, etc.) or performing tests on these samples outside of the body.

IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic purposes. This device operates by sending and receiving ultrasound waves to create images of internal structures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body for the following clinical applications: Abdominal, Cardiac, Fetal (Obstetrics), Intraoperative, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal (conventional and superficial).

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

90 IYN, IYO, ITX

Device Description

Mini Focus 1402 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. B mode includes tissue harmonic imaging. 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. The system can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. (Freehand tracking)
Transducers: Transducers are linear and convex arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Mini Focus 1402are Track 3 transducers. Acoustic output: The system controlling the Acoustic Output in Mini Focus 1402is the same as the system in 2400. The system will assure that the acoustic output always will stay below the pre-amendments 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 Mini Focus 1402 has been tested by a recognized, Certified Body.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal (conventional and superficial).

Indicated Patient Age Range

Not Found

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.

K024236 (JAN17 2003)

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

510(k) Summary:

JAN 1 4 2005

K043554
Page 1 of 2

This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.

Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Villy Braender, Regulatory Manager Date prepared: 22 December, 2004

Trade name: Ultrasound Scanner Mini Focus 1402 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 Type 2400, K024236 (JAN17 2003)

Device description:

Mini Focus 1402 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. B mode includes tissue harmonic imaging. 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.

The system can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. (Freehand tracking)

Transducers

Transducers are linear and convex arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Mini Focus 1402are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in Mini Focus 1402is the same as the system in 2400. The system will assure that the acoustic output always will stay below the pre-amendments 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 Mini Focus 1402 has been tested by a recognized, Certified Body.

Acoustic Output Reporting

1

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

Intended use.

1402 intended uses are contained within 2400-intended uses:

	Predicate device:	Submitted device:
	Ultrasound scanner Type 2400	Ultrasound scanner Mini Focus 1402
	K024236 (JAN17 2003)
Modes of operation	B, M, PWD, CFM 1) and combinations. Tissue harmonic imaging	B, M, PWD,CW, CFM 1) and combinations. Tissue harmonic imaging
Intended use(clinical application)	Abdominal
Cardiac
Fetal
Intraoperative
Neurosurgery
Obstetrics
Pediatrics
Transrectal
Small Parts (organs)
Transvaginal
Peripheral vascular
Muskulo-skeletal (conventional and superficial)	Abdominal
Cardiac
Fetal (Obstetrics)
Intraoperative
Pediatrics
Transrectal
Small Parts (organs)
Transvaginal
Peripheral vascular
Muskulo-skeletal (conventional and superficial)
Features	ECG (not monitoring)	Untracked 3D

CFM= Color Flow Mapping=Color Doppler and Amplitude 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 beamformer and operating system, modified mechanical outline and 3D imaging.

2

NAN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Villy Brænder Official Correspondent B-K Medical A/S Mileparken 34 Herlev 34, DK 2730 DENMARK

Re: K043554

Trade Name: Ultrasound Scanner Mini Focus 1402 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: December 22, 2004 Received: December 31, 2004

Dear Mr. Brænder:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your socure esternined 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of the Amendinents, of to devices 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 the general controls provisions of the Fiting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for I ins determination of substancial oqur. accuse in your premarket notification:

Transducer Model Number

8660
8665
8667

3

8670
8803
8817

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 11 your device is classified (doc acove) arols. Existing major regulations affecting your device in the It may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of reacting your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I Dri of issuantes or our device complies with other requirements of the Act that IDA has made a decorminations administered by other Federal agencies. You must or any it cach statutes and regainents, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, n.c., and manufacturing practice requirements as set CrK Fart 607), adomig (21 CFRT art 800), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I ms device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, metading acounts September 30, 1997 "Information for Manufacturers In Appendix U, (cherosou) of the Same tic Ultrasound Systems and Transducers." If the special SCCKing Manteling Orcaranter s 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 I ne special report ... CADD-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 I mis letter will anow you to begin mastering , "
notification. The FDA finding of substantial equivalence of your device to a legally marketed nontheation. The I Drivination 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 If you desire specific acressions of (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Court Court Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

4

Page 3 - Mr. Brænder

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancy Brogdon

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

Enclosure(s)

5

Diagnostic Ultrasound Indications for Use Form

System: 1402

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)	Other
(specify)
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
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
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)

Online (0000)
N= new indication; P= previously cleared by FDA; E= added under Appendix E

B+M, B+D, B+C, B+D+C. B mode includes Tissue Harmonic Imaging. Additional Comments:__________________________________________________________________________________________________________________________________________________________ D is PWD, C is Color Doppler and Amplitude 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)

Nancy C Brogdon

(Division Divisio n of Reproductive, Abdominal. and Rac iological I 510(k) Number

6

diagnostic ultrasound Indications for use form

System:	1402
Transducer:	8660

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
e Doppler
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)	P	P	P		P	P 1)	P
	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	P	P	P		P	P 1)	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: Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes Adultions: Snan Organ Breas, Roam, Portal, 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)

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

7

| System: | 1402
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Transducer: | ୫୧୧୧ ହ
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

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	Tissue
harmonic
imaging	Color
Doppler	Combined
(Specify)	Amplitude
Doppler
Ophthalmic	Ophthalmic	P	P	P	P	P	P 1)	P
Fetal Imaging
& Other	Fetal	P	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
	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 N = new Indication; P = previously cleared by TDA, E = auded and : opposition = monic Imaging, Tissue Motion Doppler, Color Velocity Imaging

B+M, B+D, B+C, B+D+C. (D is PWD, C is l))Mode combinations: Additional Comments: Auditional Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------Fetal is often called 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

Nancy C. Brogdon

ductive. Abd and Radiological Devi 510(k) Number

Prescription Use (Per 21 CFR 801.109)

・

8

System:	1402
Transducer:	8667

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

Clinical Application			Mode of Operation
Intended User	General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Amplitude
e Doppler
	Ophthalmic	Ophthalmic	P	P	P	P	P	P
		Fetal
		Abdominal
		Intra-operative (Specify)
		Intra-operative (Neuro)
		Laparoscopic
Fetal Imaging
& Other		Pediatric
		Small Organ (Specify)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal	P	P	P	P	P 1)	P
		Trans-vaginal	P	P	P	P	P	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

N= new marcation; r = previously Cleared by TDX, B = added ander + spenic Imaging, Tissue Motion Doppler, Color Velocity Imaging

B+M, B+D, B+C, B+D+C. (D is PWD, C is l))Mode combinations: Additional Comments: Auditonal Comments. Fetal is often called 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)

Nancy C. Broadon

(Divisio Division of Reproductive, Abdominal. and Radiological Devices

510(k) Number

9

System:	1402
Transducer:	8670

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	Tissue
harmonic
imaging	Color
Doppler	Combined
(Specify 1)	Amplitude
e Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify 2)	E	E	E	E	E	E	E
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging
& Other	Pediatric
	Small Organ (Specify 3)	E	E	E	E	E	E	E
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)	E	E	E	E	E	E	E
	Musculo-skel. (Superficial)	E	E	E	E	E	E	E
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	E	E	E	E	E	E	E
	Other (Specify)

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

N = new marcador, r = previousy cicaled by PDT, = = added and = = =

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, biliary system

2)Intraoperative: "Dreast, testis, 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 1 / mode oomblitude(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

Nancy brogdon
Division Sign-Off

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K043554

10

System:	1402
Transducer:	8803

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	Tissue
harmonic
imaging	Color
Doppler	Combined
(Specify)	Amplitude
Doppler
Ophthalmic	Ophthalmic	P	P	P	P	P	P 1)	P
	Fetal	P	P	P	P	P	P 1)	P
	Abdominal	P	P	P	P	P	P 1)	P
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging
& Other	Pediatric	P	P	P	P	P	P 1)	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	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

N = new Indication; P = previously cleared by FDA, E = added ander reportant =

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

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

Nancy C. hogdon

eproductive. Abdominal. Divisio and R

510(k) Number K043554

11

System:	1402
Transducer:	8817

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)	Amplitud
e Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	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 Adult	P	P	P		P	P 1)	P
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: 1) Mode combinations: B+M, B+D, 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

Nancy Hodsdon
(Division Sign-Off)

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