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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study:

The provided 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202 (K081154) does not contain information about a diagnostic study for AI/algorithm performance against acceptance criteria.

Instead, this submission is for a traditional ultrasound system and focuses on demonstrating substantial equivalence to a predicate device (B-K Medical Ultrasound Scanner Pro Focus 2202, K043524) based on technological characteristics and intended use. The "acceptance criteria" mentioned implicitly refer to safety and performance standards for diagnostic ultrasound systems as per FDA guidelines at the time (e.g., "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997").

Let's break down the information available and what is missing, based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not a submission for an AI/CAD/algorithmic device, there are no specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or acceptance criteria (e.g., "sensitivity must be >X%") against which the device performance is measured in a clinical study.

The primary "performance" discussed relates to technological characteristics and acoustic output safety.

Feature/Criterion	Acceptance Criteria (Implied by Predicate Equivalence & Standards)	Reported Device Performance (Flex Focus 1202)
Modes of Operation	Must support B, M, PWD, CFM (Color Flow Mapping/Color Doppler and Amplitude Doppler), and combinations, including Tissue Harmonic Imaging. (Based on predicate device Pro Focus 2202)	Supports B-mode (incl. Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. The table on page 2 explicitly lists these modes for various clinical applications, indicating previous FDA clearance (P) for these modes and applications.
Clinical Applications	Must support Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal. (Based on predicate device Pro Focus 2202)	Supports all listed clinical applications. The table on page 2 explicitly states "1202 intended uses are contained within 2202-intended uses" and details P-status for all these clinical applications and modes.
Simple Geometric Measurements & Calculations	Ability to perform simple geometric measurements and calculations in areas like Vascular, Urology, Cardiology, OB/GYN. (Standard for diagnostic ultrasound)	The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. Clinical measurement accuracy is stated to be described in the User Guide.
Biopsy/Puncture Guidance	Ability to guide biopsy- and puncture needles. (Standard for diagnostic ultrasound)	The system can guide biopsy- and puncture needles.
3-D Reconstruction (Optional)	Ability to reconstruct 2-D images into a 3-D volume and display. (Optional feature, likely assessed for function)	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	Must use linear arrays, convex arrays, phased arrays, and mechanical sector transducers with biocompatible patient contact materials. Track 3 transducers. (Standard for safety/performance)	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. Specific transducers (1850, 8661, 8662, 8811, 8820e, 4.00) are listed as cleared with the system.
Acoustic Output Safety	Acoustic output must stay below pre-amendments upper limits; Ispta ≤ 720 mW/cm², MI ≤ 1.9 (Track 3, non-ophthalmic), TI ≤ 6.0. (FDA standard "Information for Manufacturers...")	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 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.
Safety Testing (Thermal, Mechanical, Electrical)	Must be tested by a recognized Certified Body to ensure safety. (Regulatory requirement)	The scanner Flex Focus 1202 has been tested by a recognized Certified Body.
Substantial Equivalence	The device must have the same intended use and similar technological characteristics to a legally marketed predicate device, or differences must not raise new questions of safety/effectiveness.	The device's intended uses are contained within the predicate device's (Pro Focus 2202, K043524). Major technological characteristics are the same. Minor differences (modified scanconverter, transmitter, beamformer, mechanical outline) are considered not to raise new questions of safety or effectiveness.

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

This information is not provided as there is no diagnostic study with a "test set" in the context of an AI/algorithm. The submission is for an ultrasound system, and its "performance" is primarily demonstrated through engineering specifications, comparison to a predicate device, and compliance with general safety and performance standards for ultrasound equipment.

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

This information is not applicable/not provided. There is no "test set" requiring ground truth established by experts for a diagnostic algorithm in this submission.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" or adjudication process described as part of this traditional ultrasound system 510(k).

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a standalone ultrasound system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system designed to assist human readers.

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

This information is not applicable/not provided. The device itself is an ultrasound imaging system, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not applicable/not provided. "Ground truth" in the context of a diagnostic dataset is not discussed here, as this is a submission for an ultrasound imaging device itself, not an AI/algorithmic device requiring such a validation.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" for an AI algorithm discussed in this submission.

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

This information is not applicable/not provided. There is no "training set" or establishment of "ground truth" for it in this submission.

In summary:

The provided document is a 510(k) summary for a traditional diagnostic ultrasound system. It demonstrates substantial equivalence to a predicate device by comparing intended uses and technological characteristics, and by declaring compliance with relevant safety and performance standards for ultrasound (e.g., acoustic output limits). It does not involve any AI/CAD algorithms, and therefore, the specific types of studies, acceptance criteria, and ground truth methodologies relevant to AI/algorithmic performance are not present in this submission.

Summary

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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: +45 44528100 Fax: +45 44528199 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) andcombinations.Tissue harmonic and contrastharmonic imaging	B, M, PWD,CFM 1) andcombinations.Tissue harmonic imaging
Intended use(clinical application)	AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMusculo-skeletal	AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMusculo-skeletal

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.

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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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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Page 3 - Mr. Rasmussen

If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.

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

Enclosure(s)

: :

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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-harmonicimaging	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: 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

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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	ColorDoppler	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)
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: 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

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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	ColorDoppler	Combined(Specify)	AmplitudeDoppler
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)
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

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

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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)	AmplitudeDoppler
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)

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	Harmonicimaging	ColorDoppler	Combined(Specify 1)	AmplitudeDoppler
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)
PeripheralVessel	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

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

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	ColorDoppler	Combined(Specify)	AmplitudeDoppler
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)
PeripheralVessel	Peripheral vessel
	Other (Specify)

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}------------------------------------------------

Suctom	4 0 000	.
ranedlicar	0000Call Children Land La March &------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	1----------------

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)	AmplitudeDoppler
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)
PeripheralVessel	Peripheral vessel
	Other (Specify)

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

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.