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

Device Description

Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. 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.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the B-K Medical Ultrasound Scanner Pro Focus 2202. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a new device meets specific acceptance criteria through a clinical study in the way AI/ML devices might.

Here's an analysis based on your request, highlighting what information is available and what is typically not part of a 510(k) for an ultrasound system of this nature:

Summary of Acceptance Criteria and Device Performance for this specific document:

This document focuses on demonstrating substantial equivalence to a predicate device (B-K Medical Ultrasound Scanner Type 2400, K024236), rather than establishing novel performance acceptance criteria and then proving the device meets them through a comparative study with a "test set" and "ground truth" as might be seen for an AI/ML device.

The primary "acceptance criteria" for this 510(k) are:

Safety: Ensuring the device's thermal, mechanical, electrical safety, and acoustic output are within established limits.
Effectiveness/Intended Use: Demonstrating that the new device performs its intended functions (imaging modes, clinical applications, measurements) equivalently to the predicate device.
Technological Characteristics: Showing that any differences in technology do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly compared to predicate)	Reported Device Performance
Acoustic Output:	Max Ispta ≤ 720 mW/cm²; MI ≤ 1.9; TI ≤ 6.0 (Track 3, non-ophthalmic)	"The system controlling the Acoustic Output in Pro Focus 2202 is 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" (Acoustic Output Reporting made according to FDA guidance)
Safety Testing:	Compliance with thermal, mechanical, and electrical safety standards.	"The scanner Pro Focus 2202 has been tested by a recognized, Certified Body."
Clinical Measurement Accuracy:	Accuracy of geometric measurements and calculations for various applications.	"Clinical measurements and calculations are described and accuracies are provided in the User Guide." (No specific numerical values or studies are provided in this summary document.)
Intended Use:	To perform B-mode, M-mode, PWD mode, CFM mode for clinical applications (Abdominal, Cardiac, Fetal, etc.) as detailed for the predicate device.	The Pro Focus 2202 supports these modes and includes additional features like 3D and contrast harmonic imaging. The intended uses are stated to be "contained within 2400-intended uses." (Demonstrates functional equivalence or expansion without new risk).
Technological Equivalence:	Same major technological characteristics as predicate device.	"The predicate device has the same major technological characteristics as the subject device described above. Minor differences consist: Modified processor and operating system, modified mechanical outline and 3D imaging." (Argument for substantial equivalence).

2. Sample size used for the test set and the data provenance (country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) submission is for a diagnostic ultrasound system, not an AI/ML device that typically relies on test sets of patient data. The "tests" mentioned are for hardware safety, acoustic output, and comparison of functional specifications to a known predicate device. There is no mention of a "test set" of patient data in the context of an AI/ML study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. There is no mention of experts establishing ground truth for a test set in this kind of 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. No test set or corresponding adjudication method is discussed.

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

No. This is not a submission for an AI-assisted device. Therefore, no MRMC study or effect size related to AI assistance would be present.

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

Not Applicable. This is a hardware diagnostic imaging system; there is no standalone algorithm or AI component discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. Ground truth in the context of clinical data evaluation is not a concept explicitly applied in this type of 510(k) for an ultrasound system's core functional and safety performance. The "ground truth" for acoustic output would be adherence to physical standards and measurements. For clinical measurements, it would be the accuracy against physical phantoms or established reference methods.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, there is no ground truth established for one.

In conclusion: The provided document is a 510(k) Pre-Market Notification for a conventional diagnostic ultrasound system. Its "study" is a demonstration of substantial equivalence to an existing legally marketed device (the predicate). This involves comparing technical specifications, safety parameters (like acoustic output), and intended uses. It does not involve clinical studies with patient data, "test sets," "ground truth," or AI/ML performance metrics as would be expected for an AI-powered medical device. The "acceptance criteria" here are largely regulatory and technical compliance points to demonstrate equivalence, rather than performance goals proven through clinical data analysis.

Summary

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510(k) Summary:

JAN 1 3 2005

K043524
Page of

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: 17 December, 2004

Trade name: Ultrasound Scanner Pro Focus 2202 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:

Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode.

An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.

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 and convex arrays and mechanical sector. The patient contact materials are biocompatible.

All transducers used together with Pro Focus 2202 are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in Pro Focus 2202 is 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 Pro Focus 2202 has been tested by a recognized, Certified Body.

{1}------------------------------------------------

K8 43524
Page 2 of 2

Acoustic Output Reporting

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

Intended use.

	Predicate device:	Submitted device:
	Ultrasound scanner Type 2400	Ultrasound scanner Pro
	K024236 (JAN17 2003)	Focus 2202
Modes of operation	B, M, PWD, CFM 1) and combinations.Tissue harmonic imaging	B, M, PWD,CW, CFM 1) and combinations. Tissueand contrast harmonicimaging
Intended use(clinicalapplication)	AbdominalCardiacFetal (incl Obstetrics)IntraoperativeNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMusculo-skeletal	AbdominalCardiacFetal (incl Obstetrics)IntraoperativeNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMusculo-skeletal
Features	ECG (not monitoring)	ECG (not monitoring)3D

2202 intended uses are contained within 2400-intended uses:

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 processor and operating system, modified mechanical outline and 3D imaging.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2005

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

Re: K043524

Trade Name: Ultrasonic Scanner Pro Focus 2202 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 17, 2004 Received: December 31, 2004

Dear Mr. Brænder:

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 Ultrasonic Scanner Pro Focus 2202, as described in your premarket notification:

Transducer Model Number

1850
8661
8662

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Page 2 - Mr. Brænder

8803 8811

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, 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 (240) 276-0120. 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 (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 C. Brogdon

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

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form

System: 2202

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-andcontrastharmonicimaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify 1)	ContinousWave)
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-skeletalConventional		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:__________________________________________________________________________________________________________________________________________________________ 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)

Yancy C. Hoydon
(Division Sign-Off)

Division of Reproductive, Andominal and Radiological Devices

510(k) Number K093524

{6}------------------------------------------------

2202 System: Transducer: 1850_(with interchangeable probes_8539,6004,6005)

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)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)	P
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P
	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)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA(K002085); 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

Y. James I. Swalen

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

{7}------------------------------------------------

System:	2202
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	ColorDoppler	Combined(Specify)	Amplitudee Doppler
Ophthalmic	Ophthalmic	P	P	P		P	P 1)	P
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	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)
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: l))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)

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

Vlaric. boagton

Division f Reproductive, Abdominal, and Radiological Devic

510(k) Number K043524

{8}------------------------------------------------

System:	2202
Transducer:	8662

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 1)	Amplitudee 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)
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)_ 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

Nancy C. Roydon
Division Sign-Off

··············································································································································································

Radiological Devices
(k) Number X042524

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System:	2202
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	Harmonicimaging	ColorDoppler	Combined(Specify)	AmplitudeDoppler
Ophthalmic	Ophthalmic
Fetal Imaging& Other	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
	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	P	P	P	P	P	P 1)	P
	Cardiac Pediatric	P	P	P	P	P	P 1)	P
	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

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

Ylvia C. hogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, ind Radiological Devices

510(k) Number

{10}------------------------------------------------

System:	2202
Transducer:	8811

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	Harmonicimaging	ColorDoppler	Combined(Specify 1)	Amplitudee Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
Fetal Imaging& Other	Intra-operative (Specify 2)	P	P	P		P	P	P
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Specify 3)	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
Musculo-skel. (Superficial)		P	P	P		P	P	P
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel	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, biliary system

3)Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes l ) mode combinations: B, 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

Prescription Use (Per 21 CFR 801.109)

Nancy Ogden
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic

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.