COMBISON 530D WITH POWER DOPPLER MODE

K974813 · Medison America, Inc. · IYN · Sep 29, 1998 · Radiology

Device Facts

• Record ID: K974813
• Device Name: COMBISON 530D WITH POWER DOPPLER MODE
• Applicant: Medison America, Inc.
• Product Code: IYN · Radiology
• Decision Date: Sep 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Display of slow blood flows by displaying the Doppler backscatter amplitude of the fluid.

Device Story

Combison 530D Power Doppler is an enhanced Doppler data processing feature for the previously cleared Combison 530D diagnostic ultrasound scanner. It utilizes existing Color Doppler hardware to display color-encoded signals corresponding to the amplitude of the Doppler backscatter, enabling visualization of slow blood flows (1 to 8 cm/sec). The device is operated by clinicians in a clinical setting using electronic probes. The system processes Doppler data via a digital correlator and log compressor, outputting color-encoded images to a display. This visualization assists healthcare providers in assessing blood flow, potentially aiding in diagnostic decision-making for various clinical applications.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated through technical comparison of signal processing, wall motion filtering, and color representation against the predicate device. Acoustic output measurements were performed on production model transducers to ensure compliance with safety standards.

Technological Characteristics

Diagnostic ultrasound system using electronic probes. Features digital correlator and log compressor for Doppler signal processing. Employs 8-bit signal display for Power Doppler amplitude. Includes inline filtering and digital wall motion filters. Connectivity is integrated into the Combison 530D scanner. Software-based processing of Doppler backscatter amplitude.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organ (thyroid, testicles, breast, lymph nodes, salivary gland), and peripheral vascular applications. Includes guidance for biopsy. Prescription use only.

Regulatory Classification

Identification

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

Predicate Devices

• Toshiba SSA380 (K933743)

Submission Summary (Full Text)

{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 IYO<br>Ultrasonic Pulsed Doppler Imaging System - 90 IYN<br>Diagnostic Ultrasonic Transducer -- 90 ITX<br>(per 21 CFR sections 892.1550, 892.1560 and 892.1570) |
| Manufacturer's Name: | Medison Co., Ltd. |
| Address: | Hasung Building<br>689-3 Yeoksam-dong,<br>Kangnam-ku<br>Seoul, Korea |
| Corresponding Official: | Bob Leiker<br>Medison America, Inc.<br>6616 Owens Drive<br>Pleasanton, CA 94588 |
| Title:<br>Telephone:<br>Fax: | Vice President, Regulatory Affairs and Quality Assurance<br>[phone]<br>[phone] |
| Predicate:<br>Predicate 510(k) Number: | Toshiba SSA380<br>K933743 |
| Device Description: | See Attached |
| Intended Use: | Display of slow blood flows by displaying the Doppler<br>backscatter amplitude of the fluid. |
| Device Description: | The Power Doppler (a.k.a. Angio Doppler) is a new feature<br>of a previously cleared Combison 530D Diagnostic<br>Ultrasound scanner. The Power Doppler is an enhanced<br>Doppler data processing feature that uses previously cleared<br>Color Doppler hardware, but displays only a color encoded<br>signal corresponding to the amplitude of the Doppler signal .<br>It enables visualization of slow blood flows. The data<br>received by the doppler is processed the same way as that for<br>the color Doppler mode. The Power Doppler is used with<br>previously 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.

| OPERATING<br>MODE | 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 Mode<br>evoked by Key<br>labeled ANGIO | Angio Color Imaging, Angio Mode<br>evoked by key<br>labeled ANGIO |
| Specification | Slow flow: min 1cm/sec | Slow flow: 1 to 8 cm/sec |
| Claims | Color encoded<br>display of slow blood flows | Color encoded<br>display of slow blood flows |
| Signal to be displayed | Mean power of Doppler<br>backscatter | Mean power of Doppler backscatter |
| Colors used for representation | From low to higher amplitudes<br>dark rusty -light rusty -yellow | From low to higher amplitudes<br>Enhance 1 dark blue -light blue -yellow<br>Enhance 2,4 dark red -light red -yellow<br>Enhance 3 dark rusty -light rusty -yellow |
| Wall motion filter | Digital | Digital |
| Way of processing mean<br>value of mean P(ower)<br>P= $\sqrt{p^2}$ | Digital Correlator<br>Correlator output: P | Digital Correlator<br>Correlator output :P2,<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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 [phone].

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: _

V

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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | N | | | |
| Abdominal | | P | P | P | | P | N | | | |
| Intraoperative<br>(Specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify)* | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>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: _________________________________________________________________________________________________________________________________________________________

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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative<br>(Specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | N | | | |
| Small Organ<br>(Specify)" | | P | P | P | | P | N | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>Vascular | | P | P | P | | P | N | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | P | P | P | | P | N | | | |
| Muscular-Skeletal<br>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:

*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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative<br>(Specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | N | | | |
| Small Organ<br>(Specify)* | | P | P | P | | P | N | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>Vascular | | P | P | P | | P | N | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | P | P | P | | P | N | | | |
| Muscular-Skeletal<br>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:

...

*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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | N | | | P |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify)* | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | N | | | P |
| Transvaginal | | P | P | P | | P | N | | | P |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| 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 | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | N | | | |
| Abdominal | | E | E | E | | E | N | | E | |
| Intra-Operative (Specify) | | | | | | | | | E | Note 3 |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| 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 | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| 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-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| 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 | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | E | E | E | | E | N | | E | |
| Small Organ | | E | E | E | | E | N | | E | Note 2<br>Note 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-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| 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)