ULTRASOUND SCANNER PRO FOCUS, MODEL 2202

K043524 · B-K Medical A/S · IYN · Jan 13, 2005 · Radiology

Device Facts

• Record ID: K043524
• Device Name: ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
• Applicant: B-K Medical A/S
• Product Code: IYN · Radiology
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Pro Focus 2202 is a diagnostic ultrasound system for clinical use in abdominal, cardiac, fetal, intraoperative, neurosurgical, pediatric, transrectal, small organ, transvaginal, peripheral vascular, and musculoskeletal applications. System inputs include ultrasound signals from linear, convex, or mechanical sector arrays; optional ECG signals can be superimposed. The device processes these inputs to generate B-mode, M-mode, PWD, CW, CFM (Color/Amplitude Doppler), and tissue/contrast harmonic images. An optional 3D unit reconstructs 2D images into 3D volumes. Operated by clinicians in clinical settings, the system performs geometric measurements and calculations to assist in diagnosis and biopsy/puncture needle guidance. Output is displayed on-screen for physician review, facilitating clinical decision-making and patient management.

Clinical Evidence

Bench testing only. The device underwent safety testing by a certified body for thermal, mechanical, and electrical compliance. Acoustic output measurements were performed and confirmed to be within Track 3 limits (Ispta ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0). No clinical data was required for this 510(k) clearance.

Technological Characteristics

System utilizes linear, convex, and mechanical sector array transducers with biocompatible patient-contact materials. Operates as an ultrasonic pulsed echo and Doppler imaging system. Supports B, M, PWD, CW, CFM, and harmonic imaging modes. Includes 3D reconstruction capabilities. Acoustic output complies with Track 3 non-ophthalmic standards. Software-based processing with modified processor and OS compared to predicate.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring abdominal, cardiac, fetal/obstetric, intraoperative, neurosurgical, pediatric, transrectal, small organ, transvaginal, peripheral vascular, or musculoskeletal examinations.

Regulatory Classification

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.

Predicate Devices

• Ultrasound Scanner Type 2400 (K024236)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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: [phone] Fax: [phone] 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.

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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.<br>Tissue harmonic imaging | B, M, PWD,CW, CFM 1) and combinations. Tissue<br>and contrast harmonic<br>imaging |
| Intended use(clinical<br>application) | Abdominal<br>Cardiac<br>Fetal (incl Obstetrics)<br>Intraoperative<br>Neurosurgery<br>Pediatrics<br>Transrectal<br>Small Parts (organs)<br>Transvaginal<br>Peripheral vascular<br>Musculo-skeletal | Abdominal<br>Cardiac<br>Fetal (incl Obstetrics)<br>Intraoperative<br>Neurosurgery<br>Pediatrics<br>Transrectal<br>Small Parts (organs)<br>Transvaginal<br>Peripheral vascular<br>Musculo-skeletal |
| Features | ECG (not monitoring) | ECG (not monitoring)<br>3D |

2202 intended uses are contained within 2400-intended uses:

1) 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/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 [phone].

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-<br>and<br>contrast<br>harmonic<br>imaging | Color<br>Doppl<br>er | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify 1) | Continous<br>Wave) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P | |
| Abdominal | | P | P | P | P | P | P | | P | |
| Intraoperative (specify) | | P | P | P | P | P | P | | P | |
| Intraoperative Neurological | | P | P | P | P | P | P | | P | |
| Pediatric | | P | P | P | P | P | P | | P | |
| Small Organ (specify) | | P | P | P | P | P | P | | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | P | P | P | | P | |
| Transvaginal | | P | P | P | P | P | P | | P | |
| Transurethral | | P | P | P | P | P | P | | P | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | P | |
| Musculo-skeletal Superficial | | P | P | P | P | P | P | | P | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:__________________________________________________________________________________________________________________________________________________________ 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

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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<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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) | | | | | | | |
| Peripheral<br>Vessel | 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<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Amplitude<br>e Doppler |
| Ophthalmic | Ophthalmic | P | P | P | | P | P 1) | P |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& 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) | | | | | | | |
| Peripheral<br>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: 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<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify 1) | Amplitude<br>e 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<br>& Other | Pediatric | P | P | P | | P | P | P | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>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)_ 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<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | Harmonic<br>imaging | Color<br>Doppler | Combined<br>(Specify) | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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) | | | | | | | |
| Peripheral<br>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: 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)

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<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | Harm<br>onic<br>imagin<br>g | Color<br>Doppler | Combined<br>(Specify 1) | Amplitude<br>e Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| Fetal Imaging<br>& 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) | | | | | | | |
| Peripheral<br>Vessel | 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