Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Display of slow blood flows by displaying the Doppler backscatter amplitude of the fluid.

Device Description

The Power Doppler (a.k.a. Angio Doppler) is a new feature of a previously cleared Combison 530D Diagnostic Ultrasound scanner. The Power Doppler is an enhanced Doppler data processing feature that uses previously cleared Color Doppler hardware, but displays only a color encoded signal corresponding to the amplitude of the Doppler signal. It enables visualization of slow blood flows. The data received by the doppler is processed the same way as that for the color Doppler mode. The Power Doppler is used with previously cleared electronic probes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Combison 530D Power Doppler Mode:

Important Note: The provided document is a 510(k) Premarket Notification summary from 1997-1998 for an ultrasound device. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive "study" in the modern AI/machine learning sense. As such, many of the requested categories (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance for AI, etc.) are not applicable or not explicitly detailed in this type of regulatory submission for a traditional medical device prior to the widespread use of sophisticated AI algorithms. The "acceptance criteria" here primarily refer to meeting the performance characteristics of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device, the Toshiba SSA380 Color Angio Mode. The primary performance characteristic highlighted for the Power Doppler mode is the visualization of slow blood flows.

Acceptance Criteria (based on Predicate)	Reported Device Performance (Combison 530D Power Doppler)
Display of slow blood flows	Display of slow blood flows (1 to 8 cm/sec)
Color encoded display of slow blood flows	Color encoded display of slow blood flows
Signal to be displayed: Mean power of Doppler backscatter	Signal to be displayed: Mean power of Doppler backscatter
Wall motion filter: Digital	Wall motion filter: Digital
Bits used for P-signal display: 5	Bits used for P-signal display: 8
Filter for inline signals: Moving Average Filter	Filter for inline signals: Inline filter
Acoustic output within safe limits (MI or TI greater than 1.0 reported for specific transducer/mode combinations)	Acoustic output within safe limits (MI or TI greater than 1.0 reported for specific transducer/mode combinations)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis for various clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Peripheral Vascular, Transrectal, Transvaginal, Muscular-Skeletal Conventional, Intra-Operative)	Extended Intended Use: "N" (new) for Amplitude Doppler across all applicable clinical applications for various transducers. "E" (added under Appendix E) for B, M, PWD, CWD, Color Doppler modes and "Combined (B-M)" for some transducers.

Explanation of "Acceptance Criteria" in this context: The device is demonstrating "substantial equivalence" to a legally marketed predicate device (Toshiba SSA380). Therefore, the "acceptance criteria" are effectively that the new device's technological characteristics and intended use are as safe and effective as the predicate device, or that any differences do not raise new questions of safety or effectiveness. The table reflects a direct comparison of features to support this claim.

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

Sample Size for Test Set: Not specified. This type of 510(k) submission generally relies on a comparison of device specifications and, if necessary, limited verification and validation testing, not typically patient-based "test sets" in the clinical trial sense for AI.
Data Provenance: Not specified. The submission focuses on device design and comparison to the predicate, not clinical data from a specific country or retrospective/prospective study.

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

Number of Experts: Not applicable/not specified. For an ultrasound device, "ground truth" often refers to the physical parameters and performance measurable on phantoms or through technical specifications, not expert interpretation of images in a blinded reader study which would be more common for AI-driven diagnostic tools.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified. This would typically apply to reader studies where disagreements among expert interpretations are resolved, which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC study was not done for this submission.
Effect Size of Human Readers with/without AI: Not applicable, as this is a new ultrasound imaging mode (Power Doppler) in a traditional diagnostic device, not an AI-assisted diagnostic tool.

6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: Not applicable in the context of an AI algorithm. The device's performance as a standalone tool (the ultrasound system itself) is implied by the comparison to the predicate device's technical specifications and safety data (e.g., acoustic output).

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's performance relies on engineering specifications, technical measurements (e.g., acoustic output), and functional equivalence to the predicate device's features. For example, the ability to display slow flow (1-8 cm/sec) is a functional specification, not a diagnostic finding confirmed by pathology or outcomes data in this submission. The "Intended Use" statements for various clinical applications are based on the cleared predicate device's applications and the inherent capabilities of ultrasound.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is an ultrasound system with a new processing mode, not a machine learning model that requires a training set.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no machine learning "training set" for this device.

Summary

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

SEP 2 9 1998

)

K974813

Premarket Notification [510(k)] Summary
-----------------------------------------

Date:	December 15, 1997
Trade Name:	Combison 530D Power Doppler Mode
510(k) Number:
Common Name:	Diagnostic Ultrasound System and Transducers
Classification Name:	Ultrasonic Pulsed Echo Imaging System - 90 IYOUltrasonic Pulsed Doppler Imaging System - 90 IYNDiagnostic Ultrasonic Transducer -- 90 ITX(per 21 CFR sections 892.1550, 892.1560 and 892.1570)
Manufacturer's Name:	Medison Co., Ltd.
Address:	Hasung Building689-3 Yeoksam-dong,Kangnam-kuSeoul, Korea
Corresponding Official:	Bob LeikerMedison America, Inc.6616 Owens DrivePleasanton, CA 94588
Title:Telephone:Fax:	Vice President, Regulatory Affairs and Quality Assurance(510) 463-1830(510) 463-2646
Predicate:Predicate 510(k) Number:	Toshiba SSA380K933743
Device Description:	See Attached
Intended Use:	Display of slow blood flows by displaying the Dopplerbackscatter amplitude of the fluid.
Device Description:	The Power Doppler (a.k.a. Angio Doppler) is a new featureof a previously cleared Combison 530D DiagnosticUltrasound scanner. The Power Doppler is an enhancedDoppler data processing feature that uses previously clearedColor Doppler hardware, but displays only a color encodedsignal corresponding to the amplitude of the Doppler signal .It enables visualization of slow blood flows. The datareceived by the doppler is processed the same way as that forthe color Doppler mode. The Power Doppler is used withpreviously cleared electronic probes.

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

Track 3 Summary Table:

Track 3 Summary Table below shows each transducer / mode combination, and whether Frack 5 Summary Paction Bar TI index is greater than 1.0 for that combination. this table also indicates which modes or mode combination for which acoustic output was reported.

OPERATINGMODE	TRANSDUCER MODEL
	S-PLM5-10	S-ACA4-7	S-ACM3-5	S-NLM5-10	S-VDW5-8
B-mode		✓	✓
M-mode					✓
Pulsed Doppler	✓	✓	✓	✓	✓
CW Doppler
Color Doppler		✓	✓
Combined(specify)
Amplitude Doppler	✓1	✓1	✓1

Indicated with a "✔" is the transducer/mode combination for which the MI or TI is greater than 1.0. Measurements were made on production model transducers. than 1.0. "Measurements "For massion marked with a" " ", acoustic output table is included in a TRACK 3 section of this submission

Technological Characteristics:

Predicate Device Comparison

	Toshiba SSA380	Voluson 530 D, Power Doppler
K-file #	933743
Name of product feature	Color Angio Modeevoked by Keylabeled ANGIO	Angio Color Imaging, Angio Modeevoked by keylabeled ANGIO
Specification	Slow flow: min 1cm/sec	Slow flow: 1 to 8 cm/sec
Claims	Color encodeddisplay of slow blood flows	Color encodeddisplay of slow blood flows
Signal to be displayed	Mean power of Dopplerbackscatter	Mean power of Doppler backscatter
Colors used for representation	From low to higher amplitudesdark rusty -light rusty -yellow	From low to higher amplitudesEnhance 1 dark blue -light blue -yellowEnhance 2,4 dark red -light red -yellowEnhance 3 dark rusty -light rusty -yellow
Wall motion filter	Digital	Digital
Way of processing meanvalue of mean P(ower)P= $\sqrt{p^2}$	Digital CorrelatorCorrelator output: P	Digital CorrelatorCorrelator output :P2,P is calculated in the Log compressor
Bits used for P-signal display	5	8
Filter for inline signals	Moving Average Filter	Inline filter

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

Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 100

Bob Leiker Vice President of Regulatory Affairs and Quality Assurance Medison America, Inc. 6616 Owens Drive Pleasanton, California 94588

Re: K974813 Combison 530D Diagnostic Ultrasound Scanner with Power Doppler 055155 Regulatory Class: II/21 CFR 892.1 Product Code: 90 IYN Dated: August 26, 1998 Received: August 28, 1998

Dear Mr. Leiker:

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 Combison 530D Diagnostic Ultrasound Scanner with Power Doppler Mode, as described in your premarket notification:

Transducer Model Number

S-ACA4-7 S-PLM5-10 S-ICA5-8 S-ACM3-5 S-VDW5-8 S-NFF5-10 S-NLM5-10 S-ACP3-5

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. 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 In addition, the Food and Drug Administration (FDA) may regulatory action. 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.

{3}------------------------------------------------

Page 2 - Bob Leiker

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 Therefore, your product labeling must be consistent with FDA's CFR. Part 812 position on this use.

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 tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Page 3 - Bob Leiker

If you have any questions regarding the content of this letter, please contact
Rodrigo C. Perez at (301) 594-2222.

Sincerely yours,

for Lillian Yin, Ph.D.

Director, Division of Reproductive, Director, Director, Director, Director, Abdominal, Abdominal, and Rediological, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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

Combison 530D with Probe: S-ACA4-7

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic
Fetal		P	P	P		P	N
Abdominal		P	P	P		P	N
Intra-Operative (Specify)
Intra-Operative Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparascopic
Muscular-Skeletal Conventional
Muscular-Skeletal Superficial
Others (Specify)

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

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

Additional Comments: _

Concurrency of CDRH, Office of Device Evaluation (ODE)

Gimil L. Seyforn
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number K97481

Prescription Use (Per 21 CFR 801.109)

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

Combison 530D with Probe: S-ACM3-5

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	N
Abdominal		P	P	P		P	N
Intraoperative(Specify)
IntraoperativeNeurological
Pediatric
Small Organ(Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
PeripheralVascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others (Specify)

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

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

Additional Comments: _________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Devices Evelopition (ODE)

David A. Segerson

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K944813

Prescription Use (Per 21 CFR 801.109) V

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

Combison 530D with Probe: S-NLM5-10

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-Operative(Specify)
IntraoperativeNeurological
Pediatric		P	P	P		P	N
Small Organ(Specify)"		P	P	P		P	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
PeripheralVascular		P	P	P		P	N
Laparascopic
Muscular-SkeletalConventional		P	P	P		P	N
Muscular-SkeletalSuperficial
Others (Specify)

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

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

Additional Comments:

*Specification; thyroid gland, testicles, breast, lymph nodes, salivary gland Small Organs with a Region of Interest up to 40mm depth) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

nos of CDRH, Office

Claind C. Siyner
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K974813

Prescription Use
(Per 21 CFR 801.109)

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

Combison 530D with Probe: S-PLM5-10

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-Operative(Specify)
IntraoperativeNeurological
Pediatric		P	P	P		P	N
Small Organ(Specify)*		P	P	P		P	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
PeripheralVascular		P	P	P		P	N
Laparascopic
Muscular-SkeletalConventional		P	P	P		P	N
Muscular-SkeletalSuperficial
Others (Specify)

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

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

Additional Comments:

...

*Specification: thyroid gland testicles breast, lymph nodes, salivary gland Small Organs with a Region of Interest up to 40mm depth) _(

Concurrence of CDRH, Office of Device Eveluellian (ODE)

Daniel C. Segerstrom

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 474813 510(k) Number

6 Prescription Use . (Por 21 CFR 801-109)

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

Combison 530D with Probe: S-VDW5-8

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	N			P
Abdominal
Intraoperative(Specify)
IntraoperativeNeurological
Pediatric
Small Organ(Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	N			P
Transvaginal		P	P	P		P	N			P
Transurethral
Intravascular
PeripheralVascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others (Specify)

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

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

Additional Comments: _________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Dovice Evaluation (ODE)

David a. Segarra

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

510(k) Number K774813

Presoription Use (Per 21 CFR B01.109)

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

Combison 530D with Power Doppler

Ultrasound Device Indications Statement

510(k) Number: K974813 Device Name: Combison 530D Probe S-ACP 3-5 Transducer: 3.5MHz/60D Curved Linear Array Probe

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(B - M)	Other(Specify)
Opthalmic
Fetal	E	E	E	E	N
Abdominal	E	E	E	E	N	E
Intra-Operative (Specify)						E	Note 3
Intra-OperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral -Vascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others(Specify)

Mode of Operation

reviously cleared by FDA; E=added under Appendix E

Note 3: Includes imaging for guidance of biopsy

Concurrence of CDRH, Office of Device Evaluation(ODE)

Edwind a. Segerm
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Vrescription Use (per 21 CFR 801.109)

{11}------------------------------------------------

Indications for Use -

Ultrasound Device Indications Statement

510(k) Number:	K974813
Device Name:	Combison 530D Probe S-ICA 5-8
Transducer:	6.5MHz/10R/140D (Endocavity) Curved Linear Array Probe

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(B - M)	Other(Specify)
Opthalmic
Fetal
Abdominal
Intra-Operative (Specify)
Intra-OperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal	E	E	E	E	N	E	Note 3
Trans-Vaginal	E	E	E	E	N	E	Note 3
Trans-Urethral
Intra-Vascular
Peripheral -Vascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others(Specify)

Mode of Operation

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

Note 3: Includes imaging for guidance of biopsy

Concurrence of CDRH, Office of Device Evaluation(ODE)

David le. Hyman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological I

510(k) Number K974813

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

Ultrasound Device Indications Statement

510(k) Number: K974813 Device Name: Combison 530D Probe S-NLP 5-10 Transducer: 7.5 MHz/40mm Linear Array Probe

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(B - M)	Other(Specify)
Opthalmic
Fetal
Abdominal
Intra-Operative (Specify)
Intra-OperativeNeurological
Pediatric	E	E	E	E	N	E
Small Organ	E	E	E	E	N	E	Note 2Note 3
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral -Vascular	E	E	E	E	N	E
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others(Specify)

Mode of Operation

usly cleared by FDA: E=added under Appendix E

Note 2: Small Organ : breast, thyroid, testes, lymph node. salivary gland.
Note 3: Includes imaging for guidance of biopsy

Concurrence of CDRH, Office of Device Evaluation(ODE)

Arvil C. Hopkins
(Division Sign-Off)

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

Prescription Use (per 21 CFR 801.109)

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.