K Number

Device Name

DOPPLER-BOX

Manufacturer

COMPUMEDICS GERMANY GMGH

Date Cleared

2005-05-05

(7 days)

Product Code

IYN

Regulation Number

892.1550

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraoperative (specify): N1 (16MHz Probe) Intraoperative Neurological: N (16MHz Probe) Adult Cephalic: N (1MHz TCD Probe); P (2MHz TCD Probe, 2MHz TCD Monitoring Probe) Peripheral Vascular: p3 (Doppler-Box System); P (4MHz Pencil Probe, 8MHz Pencil); N (4MHz Monitoring)

Device Description

The Doppler-Box only contains the Doppler hardware, everything else (e.g. QL software, database) is located on a standard PC that is connected to the Doppler-Box. The probes are connected to the Doppler-Box. All sonograms are saved on the PC and can be evaluated, printed and archived. The QL software was especially designed for the Doppler-Box. At the same time, the QL software features an M-Mode. All gates are displayed in one window thus orientation is a lot easier. The Doppler-Box can be used together with the appropriate probes for the entire ultrasound diagnostic (1MHz and 2MHz Probes can work simultaneously, and functional physiological tests can be performed).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K002533, K931801

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard Doppler hardware and software for data collection, processing, and display. There is no mention of AI, ML, or related concepts like training or test sets.

Therapeutic

No.
The device is described for diagnostic ultrasound imaging and fluid flow analysis, not for treating any condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also mentions "entire ultrasound diagnostic".

SaMD (Software as a Medical Device)

The device description explicitly states that the "Doppler-Box only contains the Doppler hardware" and that probes are connected to it. While software is a component, the device includes essential hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device that interacts directly with the patient's body to obtain diagnostic information, not a device that analyzes samples taken from the body (like blood, urine, or tissue).
Device Description: The description details hardware and software for collecting and processing ultrasound data from probes connected to the patient. This aligns with an in vivo diagnostic device.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

Therefore, this device falls under the category of an in vivo diagnostic device, specifically an ultrasound system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Doppler-Box is a medical ultrasound device for measuring the blood flow velocities in arteries and The Doppler-Box is a medical ultrasound occidential linguoung in the problem.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Note 1: The 16MHz Probe can be used directly on the vessel during operation Note 2: The 1MHz Probe is a new indication the 2MHz Probes are previously cleared by FDA Note 3: The 4MHz Monitoring Probe is a new indication the 4MHz Pencil Probe is previously cleared by FDA

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

IYN, ITX

Device Description

The Doppler-Box only contains the Doppler hardware, everything else (e.g. OL software, database) is not the former of the first be consected to the Doppler Box. Misimum requir The Dopper-Box only contains in Doppier hardware, everything close very on the more of the more of the more of the more located on a standard PC that is connected in the Doppler-Box. warman are saved on the PC and can the PC. The probes are connected to the Doppier-Box. All sonograms are saved the PC. The probes are connected to the Doppler only carsoned for the Doplerthere be evaluated, printed and archived. The QL solinare was especially as a was and at the same time, the QL software features an M-Mode. All gates are displayed in one window thus oriat the same time, the QL software teatures an be used to eapley of the appropriate probes for the entire is a lot easier. The Dopler-Box can be used rogether and probe extracrania entire ultrasound diagnostic (1MHz and 2MHz Probes can work simultaneously, and functional physiological lests can be performed.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Intraoperative (specify), Intraoperative Neurological, Adult Cephalic, Peripheral Vascular

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K002533, K931801

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

MAY - 5 2005

K 051085

Valid from: 01/15/2005 Revision: 0 Page 1 of 2
Page 1 of 2
File: FDA-Summary-for-DopplerBox-rev0.doc

Doppler-Box 510 (k) 510K Summary

Stalus: F

Image /page/0/Picture/5 description: The image shows a logo with a stylized letter 'G' in a circle. Inside the 'G', there's a cursive letter 'M'. Below the circle, there's some smaller text that appears to say 'COSMETICS DIVISION'. The overall design is simple and likely represents a company or brand in the cosmetics industry.

GW / EM Written by: 01/15/2005 Oste:

510K Summary

1.	Identifying Information
Manufacturer:
Address:	Compumedics Germany GmbH
Josef-Schuettler Str. 2
D-78224 Singen
Germany
Telephone:
Fax:
E-Mail :	+49 7731 79769 0
+49 7731 79769 99
info@dwl.de
Contact :	Gerold Widenhorn / Engineering Manager
Name of Device :	Doppler-Box
2.	Class and Predicate Information
Classification Name:	Ultrasonic pulsed Doppler imaging system 892.1550
Common Name:	Ultrasound Doppler System
Proprietary Name:	Doppler-Box
Class:	Regulatory Class II
Predicate Device:	Spencer Technologies; TCD 100M, PWD13 TRANSDUCER
DWL Elektronische Systeme GmbH; Multi-Dop® X	K002533
K931801

Performance Standards ర్లుక

None Performance Standards: Performance Standards: IEC61157

Indications for Use 4.

The Doppler-Box is a medical ultrasound device for measuring the blood flow velocities in arteries and The Doppler-Box is a medical ultrasound occidential linguoung in the problem.

Device Description 5.

The Doppler-Box only contains the Doppler hardware, everything else (e.g. OL software, database) is
t the former of the first be consected to the Doppler Box . Misimum requir The Dopper-Box only contains in Doppier hardware, everything close very on the more of the more of the more of the more located on a standard PC that is connected in the Doppler-Box. warman are saved on the PC and can
the PC. The probes are connected to the Doppier-Box. All sonograms are saved the PC. The probes are connected to the Doppler only carsoned for the Doplerthere be evaluated, printed and archived. The QL solinare was especially as a was and

Valid from: 01/15/2005 Boursion: C Page 2 ol 2
File: FDA-Summary-for-Doppler Box-rev0, dos

Image /page/1/Picture/2 description: The image shows a logo with a stylized letter 'C' forming a semi-circle at the top. Inside the 'C', there's a cursive letter 'M'. Below the 'C', the word 'COMPONENTS' is written in a small, sans-serif font, and underneath that, the letters 'DWVL' are displayed in a larger, bolder font, possibly representing an acronym or brand name.

Status: F

at the same time, the QL software features an M-Mode. All gates are displayed in one window thus oriat the same time, the QL software teatures an be used to eapley of the appropriate probes for the entire is a lot easier. The Dopler-Box can be used rogether and probe extracrania
entire ultrasound diagnostice), Two probes canscrania, 4MHz and Millaneously, and luncional entire ultrasound diagnostic (1MHz and 2MHz Probes can work simultaneously, and functional physiological lests can be performed.

General Safety and Effectiveness 6.

The Dopler-Box is similar to currently distributed pulsed Doppler ultrasound systems. The Doppler The Doppler-Box is similar to currently distributed pulsed by the FDA recommended limit
signal is displayed in a FFT. Maximum acoustic output level is under by the FDA recomm and power level is displayed all the time.

Following acoustic output parameters (mean) have been measured

| Probe | ISPTA.3
(mW/cm²) | ISPPA.3
(W/cm²) | Power
[mW] | MI | TIC | PD
[us] | PRF
[Hz] |
|----------------------------|---------------------|--------------------|---------------|-------|------|------------|-------------|
| 1MHz TCD Probe | 484 | 4,84 | 206 | 0.376 | 3.22 | 20.0 | 5000 |
| 2MHz TCD Monitoring Probe | 524,5 | 17,48 | 111,2 | 0.465 | 1.99 | 20.0 | 1500 |
| 2MHz TCD Probe | 490 | 18,55 | 123.7 | 0.469 | 1.93 | 13.0 | 2000 |
| 4MHz Pencil Probe | 319.9 | 4.00 | 17.17 | 0.167 | - | 20.0 | 4000 |
| 4MHz Monitoring Probe | 635.7 | 15.89 | 42.6 | 0.318 | - | 20.0 | 2000 |
| 8MHz Pencil Probe | 434.7 | 16.72 | 18.1 | 0.199 | - | 13.0 | 2000 |
| 16MHz Intraoperative Probe | 64.0 | 0.64 | 0.722 | 0.032 | - | 5.0 | 12.000 |

· TIC for TCD Probes only

Patient Contact Material 7.

The materials of probes, coming in contact with patient are: The Thatenals POM, Epoxy Resin (all USP-Class Vi)

Software 8.

The Dopler-Box contains the hardware and software which collects and processes "rough" data The Dopler-Box contains the hardware and sonward and propiezion software is a
and sends it via network connection to a Windows® based PC . The main appliedion software is a and sends it via network connection it a vinconsing and man a phowing data on the Windows® software running on the PC, it is lecenting data, probobing and indical of the may be see calcuscreen. The main user screen shows a v 7 - spectice , " .
lated. Envelopes can be recorded and functional test can be performed.

Conclusion ਕੇ

In accordance with the FDA and based on the information provided in this Premarket notification In accordance with the FDA and based on the information provided in the ventually equivalent to predicate devices described herein.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The overall design is simple and symbolic, representing the department's role in health and human services.

Public Health Service

MAY - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Compumedics Germany GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Services 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K051085

Trade Name: Doppler-Box System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN and ITX Dated: April 26, 2005 Received: April 28, 2005

Dear Mr. Preiss:

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 the goneral controls provision, 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 Doppler-Box System, as described in your premarket notification:

Transducer Model Number

l MHz TCD Probe 2 MHz TCD Probe 2 MHz TCD Monitoring Probe 4 MHz Pencil Probe

4 MHz Monitoring 8 MHz Pencil 16 MHz Probe

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into existing major regulations affecting your device in this production in this prod if may be subject to such additional comrons. Enemage of January of Sept. In addition, FDA can be found in the Code of Feactal concerning your device in the Federal Register. may publish further announce of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a studenice complies with other requirements of the Act that FDA has made a decommancis an administered by other Federal agencies. You must or any Federal Statutes and regulations and limited to: registration and listing (21 comply will an the Act 3 requirements, nisi and as a manufacturing practice requirements as set CFR Part 807), labeling (21 CFRT art 807), good management of applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket I his letter will anow you to begin marketing your device to a legally marketed notification. The I D73 midming of bastian 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 acrise for your as (240) 276-0120. Also, please note the regulation entitled, Comaci the Office of Compunes as (21 transmit (21CFR Part 807.97). You may obtain " Misofanumig by reference to promanto nibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-204 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html

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)

Doppler-Box System

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)				N1
Intraoperative Neurological				N
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic				p2
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				p3	P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Dopler-Box System

Note 1: The 16MHz Probe can be used directly on the vessel during operation

Note 2: The 1MHz Probe is a new indication the 2MHz Probes are previously cleared by FDA

Note 3: The 4MHz Monitoring Probe is a new indication the 4MHz Pencil Probe is previously cleared

by FDA

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brandon

1MHz TCD Probe

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic				N
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

N= new indication; P= previously cleared by FDA;

Additional Comments:_

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broughton

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K051085
510(k) Number

2MHz TCD Probe

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic				P
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:_

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

(Division Sign-Off Division of Reproducti Abdomir and Radiological Devices 510(k) Number

Chapter B . p.5

2MHz TCD Monitoring Probe

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic				P
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:__________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brandon

(Division Sign-Off) Division of Reproductive, A and Radiological Device 510(k) Number

4MHz Pencil Probe

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P	P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:__________________________________________________________________________________________________________________________________________________________

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

4MHz Monitoring

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				N
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:__

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devices 1085 510(k) Number _

8MHz Pencil

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P	P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:__________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Manent Bogdan
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

Chapter B - p 9

16MHz Probe

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)				N¹		-
Intraoperative Neurological				N
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:_

Note 1: The 16MHz Probe can be used directly on the vessel during operation

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brandon

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