CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE

K050167 · Chison Medical Imaging Co., Ltd. · IYO · Feb 8, 2005 · Radiology

Device Facts

• Record ID: K050167
• Device Name: CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE
• Applicant: Chison Medical Imaging Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Feb 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for Use

Prescription Use

Device Story

CHISON 600M is an ultrasonic pulsed echo imaging system. It utilizes convex array (C60), linear array (L700), and micro-convex array (C14) transducers to acquire ultrasound signals. The system processes these signals to generate diagnostic images in B-mode, M-mode, and combined B/M modes. It is intended for use by healthcare professionals in clinical settings for diagnostic imaging of various anatomical structures, including fetal, abdominal, cardiac, and small organs. The output is displayed for clinician review to assist in clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technological comparison.

Technological Characteristics

Ultrasonic pulsed echo imaging system; includes convex (C60), linear (L700), and micro-convex (C14) transducers. Operates in B, M, and B/M modes. Complies with 21 CFR 892.1560 and 892.1570.

Indications for Use

Indicated for diagnostic ultrasound imaging in fetal, abdominal, pediatric, small organ (thyroid, parathyroid, parotid, submaxillary gland, breast), cardiac, transvaginal, peripheral vascular, and musculo-skeletal applications using B, M, and B/M modes.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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.

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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 [phone]. 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 [phone] or [phone] 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 [phone].

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)

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

| | · · · · · · · · · · · · · · · · · · · · · · · ·<br>Mode of Operation | | | | | | | | | |
|-------------------------|----------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-------------------|--------------------|
| 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) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | |
| Abdominal | | N | N | | | | | | N | |
| Intraoperative(specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric(specify) | | N | N | | | | | | N | |
| Small Organ(specify) | | N | N | | | | | | N | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | N | N | | | | | | N | |
| Transurethra | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | N | N | | | | | | N | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other(specify) | | | | | | | | | | |

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*

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## 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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

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#### 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(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

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### 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

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