Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal, Intraoperative, Pediatrics, Transrectal, Small Parts (organ), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial).

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 are linear and convex arrays and mechanical sector.

AI/ML Overview

The provided text describes a 510(k) summary for the B-K Medical Ultrasound Scanner Mini Focus 1402. The submission focuses on demonstrating substantial equivalence to its predicate device, the B-K Medical Ultrasound Scanner Type 2400 (K024236).

The safety and performance of the new device are primarily assessed through its adherence to established standards for diagnostic ultrasound systems and comparison to the predicate device, rather than through a traditional clinical study with detailed acceptance criteria and performance metrics for a novel AI algorithm. Therefore, the information requested regarding acceptance criteria, performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in submissions for AI/ML-driven devices, is not explicitly present in the provided document. This is because the device being described is a diagnostic ultrasound system, not an AI/ML diagnostic tool in the modern context.

However, based on the information provided, we can infer some "acceptance criteria" related to device specifications and safety, and how they relate to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (New Device)	Reported Device Performance (New Device)	Study/Evidence Leading to Performance
Acoustic Output (Track 3)	Should be below pre-amendment upper limits: Ispta ≤ 720 mW/cm², MI ≤ 1.9 (non-ophthalmic), TI ≤ 6.0	The system controlling Acoustic Output in Mini Focus 1402 is the same as in 2400. This system assures acoustic output always stays below the specified limits.	Comparison to predicate device and adherence to "Informations for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997"
Intended Use	Should be contained within the predicate device's intended uses. The new device's intended uses are a subset or identical to the predicate.	1402 intended uses are contained within 2400-intended uses (see detailed tables for each transducer, e.g., Fetal, Abdominal, Cardiac, Peripheral Vascular, Small Organ, etc., with 'P' indicating previously cleared). Minor new uses (marked 'E') are limited for specific transducers (e.g., Intraoperative and Musculo-skeletal for 8670).	Comparison of stated intended uses with predicate device.
Modes of Operation	Should align with or be a subset of predicate device's modes.	B, M, PWD, CFM, Tissue Harmonic Imaging, and combinations (Same as predicate, with the addition of CW).	Comparison of listed modes.
Biocompatibility	Patient contact materials must be biocompatible.	All transducers used with Mini Focus 1402 are Track 3 transducers and patient contact materials are biocompatible.	Not explicitly detailed, but stated as a fact for all transducers.
Safety Testing	Must meet thermal, mechanical, and electrical safety standards.	Tested by a recognized, Certified Body.	External certification/testing.
Clinical Measurement Accuracy	Described and accuracies provided in the User Guide.	Described and accuracies provided in the User Guide (implicitly assumed to meet standards based on predicate equivalence).	Reference to User Guide.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable in the given text. The submission relies on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards for ultrasound systems, not a specific clinical study with a "test set" in the context of an AI/ML algorithm. The "test" mentioned relates to safety testing and potentially in-house verification of specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable in the given text. There is no mention of "experts" used for establishing ground truth for a clinical "test set." The ground truth for device performance is based on adherence to established physics principles, engineering specifications, and regulatory standards for ultrasound imaging.

4. Adjudication Method for the Test Set

Not Applicable in the given text. No "adjudication method" is described as there isn't a specific clinical test set requiring expert adjudication for AI algorithm performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable in the given text. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of AI's effect on human reader performance is mentioned or relevant to this type of device clearance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable in the given text. This device is an ultrasound scanner, a hardware and software system for medical imaging, not a standalone AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For Acoustic Output: The ground truth is based on physical measurements against established regulatory limits (Ispta, MI, TI).
For Intended Use/Modes of Operation: The ground truth is comparison against the predicate device's cleared indications and modes, and regulatory classifications (e.g., "P" for previously cleared FDA indications).
For Safety: Adherence to recognized national/international thermal, mechanical, and electrical safety standards, verified by a Certified Body.
For Clinical Measurement Accuracy: This is handled through documentation in the User Guide, implying that the measurements are accurate based on known physical principles and calibration, consistent with the predicate device.

8. The Sample Size for the Training Set

Not Applicable in the given text. This is not an AI/ML device that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable in the given text. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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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:

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

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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)	AbdominalCardiacFetalIntraoperativeNeurosurgeryObstetricsPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-skeletal (conventional and superficial)	AbdominalCardiacFetal (Obstetrics)IntraoperativePediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-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.

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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

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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

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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)

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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	Tissueharmonicimaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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-skeletalConventional		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

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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	ColorDoppler	Combined(Specify)	Amplitudee 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)
PeripheralVessel	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	Tissueharmonicimaging	ColorDoppler	Combined(Specify)	AmplitudeDoppler
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)
PeripheralVessel	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

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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	ColorDoppler	Combined(Specify)	Amplitudee 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)
PeripheralVessel		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	Tissueharmonicimaging	ColorDoppler	Combined(Specify 1)	Amplitudee 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)
PeripheralVessel	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)

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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	Tissueharmonicimaging	ColorDoppler	Combined(Specify)	AmplitudeDoppler
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)
PeripheralVessel	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

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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	ColorDoppler	Combined(Specify)	Amplitude 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)
PeripheralVessel	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)

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Nancy Hodsdon
(Division Sign-Off)

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

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.