Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on enhanced Doppler data processing using existing hardware and algorithms, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as a "Diagnostic ultrasound imaging or fluid flow analysis" device, which focuses on displaying blood flow for diagnostic purposes rather than providing a therapeutic effect or treatment.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Power Doppler is a new feature of a previously cleared Diagnostic Ultrasound scanner and uses previously cleared Color Doppler hardware and electronic probes. This indicates the device is a hardware-based system with a new software feature, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device is a Diagnostic Ultrasound scanner with an enhanced feature (Power Doppler) for imaging or fluid flow analysis of the human body. It uses ultrasound waves to visualize structures and blood flow within the body.
No Sample Analysis: There is no mention of analyzing samples taken from the body. The device directly interacts with the body using ultrasound.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

Combison 530D with Probe: S-ACA4-7
Fetal: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)
Abdominal: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)

Combison 530D with Probe: S-ACM3-5
Fetal: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)
Abdominal: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)

Combison 530D with Probe: S-NLM5-10
Pediatric: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)
Small Organ (Specification; thyroid gland, testicles, breast, lymph nodes, salivary gland Small Organs with a Region of Interest up to 40mm depth): B, M, PWD, Color Doppler (P), Amplitude Doppler (N)
Peripheral Vascular: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)
Muscular-Skeletal Conventional: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)

Combison 530D with Probe: S-PLM5-10
Pediatric: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)
Small Organ (*Specification: thyroid gland testicles breast, lymph nodes, salivary gland Small Organs with a Region of Interest up to 40mm depth): B, M, PWD, Color Doppler (P), Amplitude Doppler (N)
Peripheral Vascular: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)
Muscular-Skeletal Conventional: B, M, PWD, Color Doppler (P), Amplitude Doppler (N)

Combison 530D with Probe: S-VDW5-8
Fetal: B, M, PWD, Color Doppler (P), Amplitude Doppler (N), Other (P)
Transrectal: B, M, PWD, Color Doppler (P), Amplitude Doppler (N), Other (P)
Transvaginal: B, M, PWD, Color Doppler (P), Amplitude Doppler (N), Other (P)

Combison 530D Probe S-ACP 3-5 Transducer: 3.5MHz/60D Curved Linear Array Probe
Fetal: B, M, PWD, Color Doppler (E), Amplitude Doppler (N)
Abdominal: B, M, PWD, Color Doppler (E), Amplitude Doppler (N), Combined (B - M) (E)
Intra-Operative: Combined (B - M) (E), Other (Note 3: Includes imaging for guidance of biopsy)

Combison 530D Probe S-ICA 5-8 Transducer: 6.5MHz/10R/140D (Endocavity) Curved Linear Array Probe
Trans-Rectal: B, M, PWD, Color Doppler (E), Amplitude Doppler (N), Combined (B - M) (E), Other (Note 3: Includes imaging for guidance of biopsy)
Trans-Vaginal: B, M, PWD, Color Doppler (E), Amplitude Doppler (N), Combined (B - M) (E), Other (Note 3: Includes imaging for guidance of biopsy)

Combison 530D Probe S-NLP 5-10 Transducer: 7.5 MHz/40mm Linear Array Probe
Pediatric: B, M, PWD, Color Doppler (E), Amplitude Doppler (N), Combined (B - M) (E)
Small Organ: B, M, PWD, Color Doppler (E), Amplitude Doppler (N), Combined (B - M) (E), Other (Note 2: Small Organ : breast, thyroid, testes, lymph node. salivary gland. Note 3: Includes imaging for guidance of biopsy)
Peripheral Vascular: B, M, PWD, Color Doppler (E), Amplitude Doppler (N), Combined (B - M) (E)

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

90 IYO, 90 IYN, 90 ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (thyroid gland, testicles, breast, lymph nodes, salivary gland, with a Region of Interest up to 40mm depth), Peripheral Vascular, Muscular-Skeletal Conventional, Transrectal, Transvaginal, Intra-Operative

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

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

K933743

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

Not Found

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

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
Ultrasonic Pulsed Doppler Imaging System - 90 IYN
Diagnostic Ultrasonic Transducer -- 90 ITX
(per 21 CFR sections 892.1550, 892.1560 and 892.1570)
Manufacturer's Name:	Medison Co., Ltd.
Address:	Hasung Building
689-3 Yeoksam-dong,
Kangnam-ku
Seoul, Korea
Corresponding Official:	Bob Leiker
Medison America, Inc.
6616 Owens Drive
Pleasanton, CA 94588
Title:
Telephone:
Fax:	Vice President, Regulatory Affairs and Quality Assurance
(510) 463-1830
(510) 463-2646
Predicate:
Predicate 510(k) Number:	Toshiba SSA380
K933743
Device Description:	See Attached
Intended Use:	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.

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

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
evoked by Key
labeled ANGIO	Angio Color Imaging, Angio Mode
evoked by key
labeled ANGIO
Specification	Slow flow: min 1cm/sec	Slow flow: 1 to 8 cm/sec
Claims	Color encoded
display of slow blood flows	Color encoded
display of slow blood flows
Signal to be displayed	Mean power of Doppler
backscatter	Mean power of Doppler backscatter
Colors used for representation	From low to higher amplitudes
dark rusty -light rusty -yellow	From low to higher amplitudes
Enhance 1 dark blue -light blue -yellow
Enhance 2,4 dark red -light red -yellow
Enhance 3 dark rusty -light rusty -yellow
Wall motion filter	Digital	Digital
Way of processing mean
value of mean P(ower)
P= $\sqrt{p^2}$	Digital Correlator
Correlator output: P	Digital Correlator
Correlator 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: _

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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	N
Abdominal		P	P	P		P	N
Intraoperative
(Specify)
Intraoperative
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: _________________________________________________________________________________________________________________________________________________________

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

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

...

*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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(specify)
Ophthalmic
Fetal		P	P	P		P	N	P
Abdominal
Intraoperative
(Specify)
Intraoperative
Neurological
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
Peripheral
Vascular
Laparascopic
Muscular-Skeletal
Conventional
Muscular-Skeletal
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
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
Conventional | | | | | | | | | | |
| Muscular-Skeletal
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | E | E | E | | E | N | | E | |
| Small Organ | | E | E | E | | E | N | | E | Note 2
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
Conventional | | | | | | | | | | |
| Muscular-Skeletal
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)