K Number

Device Name

CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE

Manufacturer

CHISON MEDICAL IMAGING CO., LTD.

Date Cleared

2005-02-08

(13 days)

Product Code

IYO

Regulation Number

892.1560

Intended Use

The CHISON 600M is intended for use with the following transducers: Convex Array C60, Linear Array L700, and Micro-convex Array C14. The clinical applications for the CHISON 600M with the Convex Array C60 transducer include Fetal, Abdominal, and Cardiac imaging in B, M, and Combined (B/M) modes. The clinical applications for the CHISON 600M with the Linear Array L700 transducer include Pediatric, Small Organ, Peripheral Vascular, and Musculo-skeletal imaging in B, M, and Combined (B/M) modes. Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast. The clinical application for the CHISON 600M with the Micro-convex Array C14 transducer is Transvaginal imaging in B, M, and Combined (B/M) modes.

Device Description

Not Found

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes a standard ultrasound imaging system and its intended uses and transducers. There is no mention of AI, ML, or any related technologies in the description or the sections that would typically detail such features (e.g., "Mentions AI, DNN, or ML", "Description of the training set", "Summary of Performance Studies").

Therapeutic

No
The device is described as an "Ultrasonic pulsed echo imaging system" used for various imaging applications (Fetal, Abdominal, Cardiac, etc.). Its purpose is diagnostic imaging, not therapeutic intervention.

Diagnostic

Yes

The device, an ultrasonic pulsed echo imaging system, is used for various clinical applications across multiple anatomical sites (e.g., Fetal, Abdominal, Cardiac, Musculo-skeletal). Imaging devices that generate visual representations of internal body structures are used by medical professionals to aid in the diagnosis of diseases or conditions.

SaMD (Software as a Medical Device)

The device description is not available, but the intended use clearly describes an ultrasonic pulsed echo imaging system that uses various transducers (Convex Array, Linear Array, Micro-convex Array). These are hardware components essential to generating the images, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the CHISON 600M is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens from the human body. This typically involves analyzing blood, urine, tissue samples, etc., outside of the body.
The CHISON 600M is an ultrasonic pulsed echo imaging system. Its intended use is for creating images of internal structures within the human body using ultrasound waves. This is an in-vivo (within the living body) diagnostic method, not an in-vitro one.
The listed clinical applications are all related to imaging internal anatomy. Fetal, Abdominal, Cardiac, Pediatric, Small Organ, Peripheral Vascular, Musculo-skeletal, and Transvaginal imaging are all performed directly on the patient.

Therefore, the CHISON 600M falls under the category of medical imaging devices, not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CHISON 600M is a diagnostic ultrasound system.

For the CHISON 600M system itself:
Clinical Application / Mode of Operation:

Fetal: B, M, Combined (B/M)
Abdominal: B, M, Combined (B/M)
Pediatric: B, M, Combined (B/M)
Small Organ: B, M, Combined (B/M)
Cardiac: B, M, Combined (B/M)
Transvaginal: B, M, Combined (B/M)
Peripheral Vascular: B, M, Combined (B/M)
Musculo-skeletal: B, M, Combined (B/M)

Additional Comment: Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast.

For Convex Array C60 scanhead:
Clinical Application / Mode of Operation:

Fetal: B, M, Combined (B/M)
Abdominal: B, M, Combined (B/M)
Cardiac: B, M, Combined (B/M)

Additional Comment: Abdomen include: Kidney, Liver, Pancreas, Gall bladder, Uterus etc.

For Linear Array L700 scanhead:
Clinical Application / Mode of Operation:

Pediatric: B, M, Combined (B/M)
Small Organ: B, M, Combined (B/M)
Peripheral Vascular: B, M, Combined (B/M)
Musculo-skeletal Conventional: B, M, Combined (B/M)

Additional Comments: Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and breast.

For Micro-convex Array C14 scanhead:
Clinical Application / Mode of Operation:

Transrectal: B, M, Combined (B/M)
Transvaginal: B, M, Combined (B/M)

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

90 IYO, ITX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic pulsed echo imaging

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (thyroid, parathyroid, parotid, submaxillary gland, Breast), Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal.
For Convex Array C60: Fetal, Abdominal (Kidney, Liver, Pancreas, Gall bladder, Uterus etc.), Cardiac.
For Linear Array L700: Pediatric, Small Organ (thyroid, parathyroid, parotid, submaxillary gland, breast), Peripheral Vascular, Musculo-skeletal Conventional.
For Micro-convex Array C14: Transrectal, Transvaginal.

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.

Not Found

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

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Image /page/0/Picture/3 description: The image shows the text '- 8 2005'. The text appears to be a date, with the month abbreviated to 'FEB'. The day is '8' and the year is '2005'. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chison Medical Imaging Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division and Program Manager, Third Party Review Program TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K050167

Trade Name: CHISON 600M Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: January 24, 2005 Received: January 26, 2005

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include 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 CHISON 600M, as described in your premarket notification:

Transducer Model Number

Convex Array C60 Linear Array L700 Micro-convex Array C14

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Page 2 - Mr. Borsai

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

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

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

Attachment 4.3.1 Diagnostic Ultrasound System Indications for Use Form Device Name: CHISON 600M

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

N=new indication

Additional Comment: Small organs include :thyroid, parathyroid, parotid, submaxillary

gland,and Breast

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

Nancy C. Brogdon

and Radioloo 510(k) Numb

Prescription Use

Attachment 4.3.2

CHISON 600M Ultrasound Imaging System Scanhead Indications for Use Form Device Name : Convex Array C60 -----------------------------------------------------------------------------------------------------------------------------------------------

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

N=new indication

Abdomen include: Kindey, Liver, Pancreas, Gall bladder, Uterus etc.

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

Prescription file

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,

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

Attachment 4.3.3

CHISON 600M Ultrasound Imaging System

Scanhead Indications for Use Form

Device Name :Linear Array L700

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

N=new indication

Additional Comments: Small organs include :thyroid, parathyroid, parotid, submaxillary gland, and breast

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

Nancyc brogdon
Sign Off

Prescription T

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

Attachment 4.3.4

CHISON 600M Ultrasound Imaging System Scanhead Indications for Use Form Device Name : Micro-convex Array C14

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

N=new indication

Additional Comments:

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE IF NEEDED

Prescription Drug

✓

Division Sign Off)
Division of Reproductive, Abdominal,
End Radiological Devices K050167