Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
General (Track I only)
Specific (Tracks I & III)
Ophthalmic
Fetal
Abdominal
Intra-operative (Spec.)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (Spec.)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

Device Description

The Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B (including harmonic imaging), M, Pulsed and Continuous Doppler, and Color Flow (including Amplitude Doppler). It is intended for general ultrasound imaging of the human body, with specific uses under the general applications of cardiac, peripheral vessel, and fetal imaging and other.

AI/ML Overview

The provided documentation for the Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a 510(k) premarket notification summary. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the document does not contain the explicit acceptance criteria, specific study designs, sample sizes, expert qualifications, adjudication methods, or detailed ground truth information as requested. Instead, it describes compliance with existing standards and refers to the device's intended uses.

However, I can extract and infer some information based on the typical requirements for a 510(k) submission for an ultrasound device.

Here's an attempt to address your points, with the caveat that detailed information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present a table of quantitative acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or clinical outcomes. Instead, performance is established by demonstrating compliance with recognized safety standards and substantial equivalence to predicate devices for specific clinical applications and operational modes.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (Inferred/Stated in Doc)
Acoustic Output Safety	Compliance with "Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992)" (NEMA UD-3).	Hitachi EUB-6000 Ultrasound Diagnostic Scanner complies with NEMA UD-3.
	Compliance with guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance.	Hitachi EUB-6000 Ultrasound Diagnostic Scanner complies with the guideline limits.
General Electrical Safety	Compliance with IEC 601-1 (1988) Medical Electrical Equipment, Part 1, General Requirements for Safety.	Hitachi EUB-6000 Ultrasound Diagnostic Scanner is designed to comply with IEC 601-1 (1988).
Intended Use Equivalence	The device performs the intended diagnostic ultrasound imaging and fluid flow analysis for specified clinical applications and modes of operation to a level substantially equivalent to predicate devices.	The device is determined to be substantially equivalent to legally marketed predicate devices for the specified indications for use, across various clinical applications (Fetal Imaging, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal, Cardiac, Peripheral Vessel) and modes (B, M, PWD, CWD, Color Doppler, Combined, Amplitude Doppler, Harmonic Imaging) with various transducers. The specific applications are marked 'N' (new indication) on the provided tables.
Post-Clearance Acoustic Output	Submission of a post-clearance special report containing complete acoustic output measurements based on production line devices, meeting approved levels.	This is a condition of clearance; the report is required to be submitted and must contain acceptable values to maintain 510(k) clearance.

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

Sample Size: The document does not specify any sample size for a clinical test set. 510(k) submissions for diagnostic ultrasound equipment primarily rely on engineering performance data, compliance with standards, and comparison to predicate devices, rather than de novo clinical trial data.
Data Provenance: Not applicable, as detailed patient data or clinical study data is not presented. The "study" here refers to the demonstration of compliance with standards and the technical specifications that show equivalence.

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

This information is not provided in the document. A 510(k) for a diagnostic ultrasound does not typically require a human-read diagnostic performance study with expert-established ground truth in the same way an AI/CADe device might. The focus is on the technical capability of the imaging system.

4. Adjudication Method for the Test Set

Not applicable, as a clinical test set with adjudicated ground truth is not described.

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, an MRMC comparative effectiveness study was not done. This device is a diagnostic ultrasound scanner, not an AI or CADe (Computer-Aided Detection/Diagnosis) system designed to assist human readers. Thus, there is no AI component for human readers to improve with or without.

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

No, a standalone algorithm performance study was not done. This is a hardware imaging device, not a standalone algorithm.

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

For the purpose of this 510(k), the "ground truth" for the device's performance relies on compliance with established engineering standards (e.g., NEMA UD-3, IEC 601-1) for acoustic output and electrical safety, and the technical specifications demonstrating that the device can acquire images suitable for the listed clinical applications in various modes, similar to its predicate devices. There is no mention of pathology, expert consensus on clinical cases, or outcomes data in this summary.

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic ultrasound scanner; it is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device would relate to engineering design and testing, not data-driven model training.

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

Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided document demonstrates the Hitachi EUB-6000 Ultrasound Diagnostic Scanner meets acceptance criteria primarily through compliance with recognized safety and performance standards and by establishing substantial equivalence to existing legally marketed predicate ultrasound devices for its specified intended uses. It is crucial to understand that a 510(k) submission for a primary imaging device like this differs significantly from submissions for AI/CADe software, which would typically contain the detailed performance study information you requested.

Summary

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

Hitachi EUB-6000 Ultrasound Diagnostic Scanner K994026

MAR 2 9 2000

SUMMARY OF SAFETY AND EFFECTIVENESS Hitachi EUB-6000 Ultrasound Diagnostic Scanner

Device Description

Safety

As a Track 3 ultrasound device, the Hitachi EUB-6000 Ultrasound Diagnostic Scanner complies with the "Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992)", published by the National Electrical Manufacturers Association as UD-3. With respect to limits on acoustic outputs, the Hitachi EUB-6000 Ultrasound Diagnostic Scanner complies with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the Hitachi EUB-6000 Ultrasound Diagnostic Scanner is designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1, General Requirements for Safety.

Section 4.2 Page 4

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2000

Charles F. Hottinger, Ph.D. Director, Regulatory Affairs Hitachi Medical Corporation of America Hitachi Medical Systems 660 White Plains Road Tarrytown, NY 10591-5107

K994026 Re: Hitachi EUB-6000 Ultrasound Diagnostic Device Regulatory Class: II Product Code: 90 IYN/21 CFR 892.1550 and 90 IYO/21 CFR 892.1560 Dated: February 25, 2000 Received: February 29, 2000

Dear Dr. Hottinger:

We have reviewed your Section 510(k) 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 Hitachi EUB-6000 Ultrasound Diagnostic Device, as described in your premarket notification:

Transducer Model Numbers

EUP-B314. EUP-C314G. EUP-ES322. EUP-ES52M EUP-ES533, EUP-F531, EUP-L34T, EUP-L53S, EUP-OL334 EUP-R53W, EUP-S31T, EUP-TC3, EUP-U533 and EUP-V53W

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 -Charles F. Hottinger, Ph.D.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Daniel A. Lyon
by Daniel C. Schultz, M.D.

aniel G Schultz Captain, USPHS Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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System:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
A - Station Comments of Children Market All - A A B - A B - A B - A B - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Comments of the many of the more of the All All All All All A di A A divis A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N
	Abdominal	Na	Na	Na	Na	Na	Na	Na
	Intra-operative (Spec.)	Nb	Nb	Nb		Nb	Nb	Nb
	Intra-operative (Neuro.)	N	N	N		N	N	N
Fetal Imaging& Other	Laparoscopic	N	N	N		N	N	N
	Pediatric	N	N	N	N	N	N	N
	Small Organ (Spec.)	Nd	Nd	Nd		Nd	Nd	Nd
	Neonatal Cephalic	N	N	N		N	N	N
	Adult Cephalic	N	N	N	N	N	N	N
	Trans-rectal	Nh	Nh	Nh		Nh	Nh	Nh
	Trans-vaginal	Nf	Nf	Nf		Nf	Nf	Nf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	N	N	N		N	N	N
	Musculo-skel. (Superfic.)	N	N	N		N	N	N
	Intra-luminal
	Other (spec.)
	Cardiac Adult	N	N	N	N	N	N	N
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	N
	Trans-esophageal (card.)	Ng	Ng	Ng		Ng	Ng	Ng
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	N	N
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy Subscript "d":

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Includes imaging for guidance of transvaginal biopsy. Subscript "f":

Subscript "g": Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Sezman

Division of Reprodu and Radiological D

510(k) Number: K994026

{4}------------------------------------------------

System: Transducer

EUB-6000

EUP-B314

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

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N		N	N	N
	Abdominal	Na	Na	Na		Na	Na	Na
	Intra-operative (Spec.)	Nb	Nb	Nb		Nb	Nb	Nb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
----------------	--------------------------------------------------------------------------------------------------------------------

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy.

Subscript "g": Includes pediatric patients.

Includes imaging for guidance of transrectal biopsy. Subscript "h":

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Syzman

Sion Division of Reproductive, Abe dominal. P and Radiologic

510(k) Number: K944026

{5}------------------------------------------------

System: Transducer

EUB-6000 EUP-C314G

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

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N
	Abdominal	Na	Na	Na		Na	Na	Na
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ (Spec.)	Nd	Nd	Nd		Nd	Nd	Nd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy
Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy

Subscript "g": Includes pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seaymon

Division of Reproductive, Abdomin

510(k) Numbe

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

System: Transducer

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

EUB-6000 EUP-ES322

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

Clinical Application						Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)	N	N	N		N	N	N
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
----------------	--------------------------------------------------------------------------------------------------------------------

Includes imaging of organs and structures exposed during surgery Subscript "b":

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis. Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy Subscript "d":

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy.

Subscript "g": Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leggett

(Division Sign-Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number: K994026

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

System: Transducer

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000

EUP-ES52M

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

Clinical Application						Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)	N	N	N	N	N	N	N
	Other (spec.)
	PeripheralVessel	Peripheral vessel
Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Includes imaging of organs and structures exposed during surgery Subscript "b":

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy

Subscript "e": Includes imaging for guidance of transrectal biopsy. Subscript "f": Includes imaging for guidance of transvaginal biopsy.

Subscript "g":

Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel h. Se yman

Division Sion-6 Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number: K944026

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

System:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

EUB-6000 Transducer EUP-ES533

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

Clinical Application						Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)	Ng	Ng	Ng	Ng	Ng	Ng	Ng
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including Subscript "a": amniocentesis).

Includes imaging of organs and structures exposed during surgery Subscript "b":

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Heyman

Division Sign-Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number:

Prescription Use (Per 21 CFR 801.109)

{9}------------------------------------------------

EUB-6000

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Transducer

EUP-F531

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

	Clinical Application					Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N
	Intra-operative (Spec.)	Nb	Nb	Nb		Nb	Nb	Nb
	Intra-operative (Neuro.)	N	N	N		N	N	N
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ (Spec.)	Nc	Nc	Nc		Nc	Nc	Nc
	Neonatal Cephalic	N	N	N		N	N	N
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N
	Trans-vaginal	N	N	N		N	N	N
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	N
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy
Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy.

Subscript "g": Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segmen

(Division Sign-C Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)

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

System:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

EUB-6000 EUP-L34T

Transducer

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

	Mode of Operation
Clinical Application	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
General(Track I only)	Ophthalmic
Ophthalmic	Fetal
	Abdominal	Na	Na	Na		Na	Na	Na
	Intra-operative (Spec.)
	Intra-operative (Neuro.)	N	N	N		N	N	N
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ (Spec.)	Nd	Nd	Nd		Nd	Nd	Nd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	N	N	N		N	N	N
	Musculo-skel. (Superfic.)	N	N	N		N	N	N
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	N
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including Subscript "a": amniocentesis).

Includes imaging of organs and structures exposed during surgery Subscript "b":

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy

Subscript "e": Includes imaging for guidance of transrectal biopsy. Includes imaging for guidance of transvaginal biopsy.

Subscript "f":

Subscript "g": Includes pediatric patients. Subscript "h":

Includes imaging for guidance of transrectal biopsy. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

Division Sign Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K944026

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System: Transducer EUB-6000 EUP-L53S

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

Clinical Application	Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other **(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Na	Na	Na		Na	Na	Na
	Intra-operative (Spec.)
	Intra-operative (Neuro.)	N	N	N		N	N	N
Fetal Imaging	Laparoscopic
& Other	Pediatric	N	N	N		N	N	N
	Small Organ (Spec.)	Nd	Nd	Nd		Nd	Nd	Nd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	N	N	N		N	N	N
	Musculo-skel. (Superfic.)	N	N	N		N	N	N
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	N	N	N		N	N	N
Vessel	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy
Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy.

Subscript "g": Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David a. Seymour

Division of Reproductive, Abdominal, ENT and Radiological D

510(k) Number: K994026

{12}------------------------------------------------

EUP-OL334

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000

System: Transducer

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

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic	N	N	N		N	N	N
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Leyson

Division of Reproductive, Abdominal, El and Radiological

510(k) Number: K944024

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EUP-R53W

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000

System: Transducer

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

General(Track I only)	Clinical Application		Mode of Operation
	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy Subscript "d":

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Styron

Division Sign-Division of Reproductive, Abdominal, EL and Radiological D 510(k) Number:

{14}------------------------------------------------

System: Transducer

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

EUB-6000 EUP-S31T

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

Clinical Application	Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N
	Abdominal	N	N	N	N	N	N	N
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N	N	N	N	N
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	N	N	N	N	N	N	N
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	N
	Trans-esophageal (card.)
	Other (spec.)

PeripheralVessel	Peripheral vessel	N	N	N	N	N	N	N
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments: તે

Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
----------------	--------------------------------------------------------------------------------------------------------------------

Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyons

(Division Sign-Division of Reproductive, Abdominal, EN and Radiological Device

510(k) Number:

{15}------------------------------------------------

System: Transducer DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000

EUP-TC3

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

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult				N
Cardiac	Cardiac Pediatric				N
	Trans-esophageal (card.)
	Other (spec.)

PeripheralVessel	Peripheral vessel				N
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery.

Subscript "b" Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "d":

Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy.

Subscript "g": Includes pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seaman

(Division Sign-Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Numbe

Prescription Use (Per 21 CFR 801.109)

{16}------------------------------------------------

System: Transducer

EUB-6000

EUP-U533

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
and and the company of a many of the first and any of the champion of the country of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

and and the company of a many of the first and any of the champion of the country of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Clinical Application			Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	Nh	Nh	Nh		Nh	Nh	Nh
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy Subscript "d":

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy

Includes pediatric patients. Subscript "g":

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segmen

Division of Re anı

510(k) Numb

Prescription Use (Per 21 CFR 801.109)

{17}------------------------------------------------

System:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

EUB-6000 EUP-V53W

Transducer

			Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
		.	Comments of the control of the control of the control controllation of the comments of the comments of the comments of

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	Ne	Ne	Ne		Ne	Ne	Ne
	Trans-vaginal	Nf	Nf	Nf		Nf	Nf	Nf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication.

*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy.

Subscript "g": Includes pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Leggmm
(Division Sigff-Off)

Division of Reproductive, Abdominal, ENT and Radiologic

510(k) Numbe

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.