EBit Series Diagnostic Ultrasound System

• K Number: K162172
• Device Name: EBit Series Diagnostic Ultrasound System
• Manufacturer: CHISON MEDICAL IMAGING CO., LTD.
• Date Cleared: 2016-09-14 ( 42 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.

Device Description

The EBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

Predicate Devices

K153085

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and processing techniques (autocorrelation, FFT) and does not mention any AI or ML capabilities.

Therapeutic

No.
The device is described as a "Diagnostic Ultrasound System" intended for "clinical diagnostic imaging applications" and does not mention any therapeutic capabilities or functions.

Diagnostic

Yes

The device description explicitly states, "The EBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color doppler ultrasound imaging system" consisting of a "mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes." This indicates the device includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states that the device is a general-purpose ultrasonic instrument for evaluation of various anatomical sites. This involves imaging and visualization of internal structures.
• Device Description: The description details an ultrasound imaging system that acquires and displays ultrasound echo data in various modes (B-Mode, M-Mode, Doppler, etc.). This is consistent with diagnostic imaging, not in vitro testing.
• Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device operates by transmitting and receiving ultrasound waves within the body.
• No Mention of Specimen Analysis: There is no mention of analyzing biological specimens or performing tests on samples.
• Focus on Imaging: The entire description revolves around the process of generating and displaying ultrasound images.

In summary, this device is a diagnostic imaging system that uses ultrasound to visualize internal structures, which is distinct from the function of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.

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

IYN, IYO, ITX

Device Description

The EBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Transesophageal, Transrectal, Transvaginal, Urology.

Indicated Patient Age Range

Adult, Pediatric, Neonatal (Cephalic only), Fetal

Intended User / Care Setting

Qualified physician / Hospitals, clinics usage

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)

Non-Clinical Tests: The EBit Series Diagnostic Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.

Clinical Test: No clinical testing was required.

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.

Q Series Diagnostic Ultrasound System K153085

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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 14, 2016

CHISON Medical Imaging Co., Ltd. % Mr. Bob Leiker Owner Leiker Regulatory & Ouality Consulting 4157 North Del Rey Avenue CLOVIS CA 93619

Re: K162172

Trade/Device Name: EBit Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 25, 2016 Received: August 18, 2016

Dear Mr. Leiker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michal D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162172

Device Name

EBit Series Diagnostic Ultrasound System

Indications for Use (Describe)

The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Diagnostic Ultrasound Indications For Use

System: EBit Series Diagnostic Ultrasound System

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

Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal	N	N	N		N	N	N	3,5,6
	Abdominal	N	N	N		N	N	N	3,4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic	N	N	N	N	N	N	N	6,7
	Adult Cephalic	N	N	N	N	N	N	N	6,7
	Trans-rectal	N	N	N		N	N	N	4,5,6
	Trans-vaginal	N	N	N		N	N	N	3,4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	5,6,7
	Cardiac Pediatric	N	N	N	N	N	N	N	5,6,7
	Transesophageal	N	N	N	N	N	N	N	6,7
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5.6

N = new indication; P = previously cleared by FDA;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM , B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

3.3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

4

System: EBit Series Diagnostic Ultrasound System Transducer: C3-E

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal	N	N	N		N	N	N	5,6
	Abdominal	N	N	N		N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PW or CW 2. Small Organ: thyroid, testes, breast

• 3.3D/4D

4. Elastography

5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

Prescription Use_ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

5

System: EBit Series Diagnostic Ultrasound System Transducer: C3S-E

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

Clinical Application			Mode of Operation							Other
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal	N	N	N		N	N	N	5,6
Other	Abdominal	N	N	N		N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

N = new indication; P = previously cleared by FDA;

E = added under this appendix Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3.3D/4D
• 4. Elastographv
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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System: EBit Series Diagnostic Ultrasound System Transducer: C3S-D

Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal	N	N	N	N	N	N	N	5,6
	Abdominal	N	N	N	N	N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
Cardiac	Other (Urology)	N	N	N	N	N	N	N	5,6
	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM ,B+PW, B/Color M, B/BC,B/PW or CW,B/CFM/PW or CW,B/PD or DPD/PW 2. Small Organ: thyroid, testes, breast

3.3D/4D

4. Elastography

5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

Prescription Use メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

7

EBit Series Diagnostic Ultrasound System System: Transducer: C3S-ES

Clinical Application		Mode of Operation							Other
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal	N	N	N		N	N	N	5,6
	Abdominal	N	N	N		N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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 this appendix

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3.3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

8

EBit Series Diagnostic Ultrasound System System: Transducer: L7-E

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

Clinical Application		Mode of Operation							Other
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3.3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

9

System: EBit Series Diagnostic Ultrasound System Transducer: L7-ES

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

Clinical Application		Mode of Operation							Other
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

10

System: EBit Series Diagnostic Ultrasound System Transducer: L7W-E

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ [1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

11

System: EBit Series Diagnostic Ultrasound System Transducer: L18-E

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

Clinical Application		Mode of Operation							Other
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N	N	N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	4,5,6
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

12

System: EBit Series Diagnostic Ultrasound System Transducer: L12-E

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

13

System: EBit Series Diagnostic Ultrasound System Transducer: L12-D

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

14

System: EBit Series Diagnostic Ultrasound System Transducer: i7L-E

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)	N	N	N	N	N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	4,5,6
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

15

System: EBit Series Diagnostic Ultrasound System Transducer: L7R-E

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

Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	4,5,6
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

16

System: EBit Series Diagnostic Ultrasound System Transducer: V6-E

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

17

System: EBit Series Diagnostic Ultrasound System Transducer: V7-E

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N	N	N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3.3D/4D
• 4. Elastographv
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

× AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

18

EBit Series Diagnostic Ultrasound System System: Transducer: V7W-E

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3.3D/4D
• 4. Elastographv
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

× AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

19

System: EBit Series Diagnostic Ultrasound System Transducer: V7-D

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

Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N	N	N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

20

EBit Series Diagnostic Ultrasound System System: Transducer: V7-ES

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N	N	N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3.3D/4D
• 4. Elastographv
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

× AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

21

System: EBit Series Diagnostic Ultrasound System Transducer: 7B8-E

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

Clinical Application		Mode of Operation							Other
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N	N	N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3.3D/4D
• 4. Elastographv
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

× AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

22

System: EBit Series Diagnostic Ultrasound System Transducer: V6-EV

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

Clinical Application		Mode of Operation							Other
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	N	N	3,4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3.3D/4D

4. Elastographv

5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

× AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

23

System: EBit Series Diagnostic Ultrasound System Transducer: MC5-E

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

Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal	N	N	N		N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult	N	N	N		N	N	N	5,6
	Cardiac Pediatric	N	N	N		N	N	N	5,6
	Transesophageal
Peripheral Vessel	Peripheral vessel

N = new indication; P = previously cleared by FDA;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

24

System: EBit Series Diagnostic Ultrasound System Transducer: MC3-E

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal	N	N	N		N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult	N	N	N		N	N	N	5,6
	Cardiac Pediatric	N	N	N		N	N	N	5,6
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

25

System: EBit Series Diagnostic Ultrasound System Transducer: MC6-E

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal	N	N	N	N	N	N	N	5,6
	Abdominal	N	N	N	N	N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PW or CW 2. Small Organ: thyroid, testes, breast

• 3.3D/4D

4. Elastography

5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

26

System: EBit Series Diagnostic Ultrasound System Transducer: P3-E

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N	6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	5,6,7
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PW or CW 2. Small Organ: thyroid, testes, breast

3.3D/4D

4. Elastography

5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

27

System: EBit Series Diagnostic Ultrasound System Transducer: P2-E

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW	CW	Color	Power
Doppler Doppler Doppler Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N	6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	5,6,7
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging

7. TDI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

28

EBit Series Diagnostic Ultrasound System System: Transducer: P2-ES

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N	6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	5,6,7
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use_ Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

29

EBit Series Diagnostic Ultrasound System System: Transducer: P6-E

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic	N	N	N	N	N	N	N	6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	N	5,6,7
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PW or CW 2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

30

System: EBit Series Diagnostic Ultrasound System Transducer: CW2-E

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

Clinical Application		Mode of Operation							Other
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic				N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult				N
	Cardiac Pediatric				N
	Transesophageal
Peripheral Vessel	Peripheral vessel				N

N = new indication;

P = previously cleared by FDA;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PW or CW 2. Small Organ: thyroid, testes, breast

• 3.3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

31

System: EBit Series Diagnostic Ultrasound System Transducer: V4-EV

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal	N	N	N	N	N	N	N	3,6
	Abdominal	N	N	N	N	N	N	N	3,4,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

3.3D/4D

4. Elastography

5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

32

System: EBit Series Diagnostic Ultrasound System Transducer: T5-E

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

Clinical Application		Mode of Operation							Other
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal	N	N	N	N	N	N	N	6,7
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

33

System: EBit Series Diagnostic Ultrasound System Transducer: MT5-E

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal	N	N	N	N	N	N	N	6,7
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM ,B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW 2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

34

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

1. Submitter:

Submitter:	Chison Medical Imaging Co., Ltd.
Address:	No.228, ChangJiang East Road, Block 51 and 53,
	Phase 5 Industrial Park, Shuo Fang, New District,
	Wuxi 214142, China
	No. 9 Xin Hui Huan Road, New District, WuXi P. R. China
Contact:	Mr. Liu Qifei
Tel:	[phone]
Fax:	[phone]
Date Prepared:	June 15, 2016

2. Device :

Trade Name: EBit Series Diagnostic Ultrasound System

Common Name: Diagnostic Ultrasound System with Accessories

Classification: Regulatory Class: II

Review Category: Tier II

Classification Name	21 CFR Section	Product Code
Ultrasonic pulsed doppler imaging system	892.1550	90-IYN
Ultrasonic pulsed echo imaging system	892.1560	90-IYO
Diagnostic ultrasonic transducer	892.1570	90-ITX

3. Predicate Device(s):

Q Series Diagnostic Ultrasound System 510(k) Number: K153085

4. Device Description:

The EBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

35

5. Indications for Use:

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Transesophageal, Transrectal, Transvaginal, Urology.

6. Summarv of Non-Clinical Tests:

The EBit Series Diagnostic Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.

The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.

IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General Requirements for Safety

IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility --Requirements and Tests.

IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.

NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

7. Clinical Test:

No clinical testing was required.

8. Comparison to Predicate Device:

	Predicate Device	Submission Device
Product Name
(K number)	Q Series Diagnostic
Ultrasound System
K150861	EBit Series Diagnostic
Ultrasound System	Remark
Indications for
Use	Fetal
Abdominal
Pediatric
Small Organ (breast, thyroid, testes)
Neonatal Cephalic, Adult
Cephalic	Fetal
Abdominal
Pediatric
Small Organ (breast, thyroid, testes)
Neonatal Cephalic, Adult
Cephalic, Transrectal,	Same
	Predicate Device	Submission Device
Product Name
(K number)	Q Series Diagnostic
Ultrasound System
K150861	EBit Series Diagnostic
Ultrasound System	Remark
	Transrectal, Transvaginal,
Musculo-skeletal
(Conventional, Superficial)
Cardiac(adult, pediatric)
Peripheral Vascular
Urology
Transesophageal	Transvaginal,
Musculo-skeletal (Conventional,
Superficial)
Cardiac(adult, pediatric)
Peripheral Vascular
Urology
Transesophageal
Design	Autocorrelation for color
processing and FFT for pulse
and CW Doppler processing.
Supporting: Linear, Curve,
Phase array and Volume
probes.
Cine play back capability
Image file archive	Autocorrelation for color
processing and FFT for pulse
and CW Doppler processing.
Supporting Linear, Curve,
Phase array and Volume
probes.
Cine play back capability
Image file archive	Same
Operating	TGC 8 slider	TGC 8 slider	Same
Controls	Depth Range: 0 to 30 cm	Depth Range: 0 to 30.8 cm	SE
Analysis 1
	256 shades of gray	256 shades of gray	Same
	B Dynamic range control: 30-
180 dB, 5/step	B Dynamic range control: 30-
180 dB, 5/step	Same
	Gain:0-255,1/step	Gain:0-255,1/step	Same
	Focal Number:1-4	Focal Number:1-4	Same
	Focus position: adjustable	Focus position: adjustable	Same
	B steer: available on linear
transducers	B steer: available on linear
transducers	Same
	B Persistence: 7 steps	B Persistence: 7 steps	Same
	ROI size/position: adjustable	ROI size/position: adjustable	Same
	Color Wall Filter settings:8
steps	Color Wall Filter settings:8 steps	Same
	Color Baseline: 16 steps	Color Baseline: 16 steps	Same
	Color Maps: 21 maps	Color Maps: 21 maps	Same
	Color Invert: on/off	Color Invert: on/off	Same
	PW sweeping speed: 6 steps	PW sweeping speed: 6 steps	Same
	PW Wall Filter: 7 steps	PW Wall Filter: 7 steps	Same
	PW sample volume: 0.5-30mm
(PW only), 13 steps	PW sample volume: 0.5-30mm
(PW only), 13 steps	Same
	PW angle correction:
-89~89degrees, 1/step	PW angle correction:
-89~89degrees, 1/step	Same
	Baseline: 8steps	Baseline: 8steps	Same
	Cine control: step, play
backward, play continuously	Cine control: step, play
backward, play continuously	Same
	Doppler Auto Trace	Doppler Auto Trace	Same
	Freeze control: Toggling freeze
key	Freeze control: Toggling freeze
key	Same
	Predicate Device	Submission Device
Product Name
(K number)	Q Series Diagnostic
Ultrasound System
K150861	EBit Series Diagnostic
Ultrasound System	Remark
Safety
Compliance	IEC60601-1 Medical electrical
equipment - Part 1: General
requirements for safety
IEC60601-1-2 Medical
electrical equipment - Part 1-2:
General requirements for
safety - Collateral standard:
Electromagnetic compatibility -
Requirements and tests
IEC60601-2-37 Medical
electrical equipment - Part 2-
37: Particular requirements for
the safety of ultrasonic medical
diagnostic and monitoring
equipment
ISO 10993-1 Biological
evaluation of medical devices -
Part 1: Evaluation and testing
within a risk management
process	IEC60601-1 Medical electrical
equipment - Part 1: General
requirements for safety
IEC60601-1-2 Medical electrical
equipment - Part 1-2: General
requirements for safety -
Collateral standard:
Electromagnetic compatibility -
Requirements and tests
IEC60601-2-37 Medical
electrical equipment - Part 2-37:
Particular requirements for the
safety of ultrasonic medical
diagnostic and monitoring
equipment
ISO 10993-1 Biological
evaluation of medical devices -
Part 1: Evaluation and testing
within a risk management
process	Same
	Operation Mode B, THI, M, Color M, Free
Steering M mode, Color
Doppler Imaging, Power
Doppler Imaging / Directional
PD, Pulsed Wave Doppler,
Continuous Wave Doppler,
TDI, Contrast Imaging, 3D/ 4D,
Elastography, Curved
Panoramic, Trapezoidal image	B, THI, M, Color M, Free
Steering M mode, Color Doppler
Imaging, Power Doppler
Imaging / Directional PD,
Pulsed Wave Doppler,
Continuous Wave Doppler, TDI,
Contrast Imaging, 3D/ 4D,
Elastography, Curved
Panoramic, Trapezoidal image	Same
Display Modes	B, M, PW, CW, CFM,
Power/Dir Power, TDI, 3D/4D;
B+M, B+PW, B+CFM,
B+PD/DPD, B+CFM+PW/CW,
B+PW+PD/DPD	B, M, PW, CW, CFM, Power/Dir
Power, TDI, 3D/4D;
B+M, B+PW, B+CFM,
B+PD/DPD, B+CFM+PW/CW,
B+PW+PD/DPD	Same
Display
Annotations	Logo; Hospital Name; Exam
date; Exam time; Acoustic
Power; Mechanical index;
Tissue thermal indes; ID, Last
name, First Name, Middle
initial, Gender, Age; Probe
model; ECG ico; Operator;
TGC Curve; Focus position;
Thumbnail; Imaging
parameters; Dynamic Trackball
indices	Logo; Hospital Name; Exam
date; Exam time; Acoustic
Power; Mechanical index;
Tissue thermal indes; ID, Last
name, First Name, Middle initial,
Gender, Age; Probe model;
ECG ico; Operator; TGC Curve;
Focus position; Thumbnail;
Imaging parameters; Dynamic
Trackball indices	Same
	Predicate Device	Submission Device
Product Name
(K number)	Q Series Diagnostic
Ultrasound System
K150861	EBit Series Diagnostic
Ultrasound System	Remark
Display Monitor	15"high-resolution color LCD
monitor	15" high-resolution color LCD
monitor	Same
Measurements	2D mode: Depth, Distance,
Area: Ellipse, Trace, Spine,
Cross, Trace Length, Double
Distance, Parallel, Volume
Distance, Ellipse, Ellipse +
Distance, Length Ratio, Area
Ratio , IMT, B Histogram, B
Profile, Volume Flow, Color
Velocity;
M mode: Distance, Time,
Slope, Heart Rate, Velocity;
Doppler mode: D Velocity
,Time ,Heart Rate,
Acceleration, D Trace, PS/ED,
Volume Flow;	2D mode: Depth, Distance,
Area: Ellipse, Trace, Spleen,
Cross, Trace Length, Double
Distance, Parallel, Volume
Distance, Ellipse, Ellipse +
Distance, Length Ratio, Area
Ratio , IMT, B Histogram, B
Profile, Volume Flow, Color
Velocity;
M mode: Distance, Time, Slope,
Heart Rate, Velocity;
Doppler mode: D Velocity ,Time
,Heart Rate, Acceleration, D
Trace, PS/ED, Volume Flow;	Same
Transducer
Types &
Connectors	Convex Array, Phased Array,
Linear Array, Volume probe
2ports	Convex Array, Phased Array,
Linear Array, Volume probe
2ports	Same
Users / Sites	Hospitals, clinics usage	Hospitals, clinics usage	Same
Acoustic Output	Track 3; MI, TIS, TIC, TIB
Derated Ispta: 720mW/cm²
maximum, TIS/TIB/TIC:0.1-4.0
Range, Mechanical Index: 1.9
Maximum, or Derated Isppa:
190 W/cm² max	Track 3; MI, TIS, TIC, TIB
Derated Ispta: 720mW/cm²
maximum, TIS/TIB/TIC:0.1-4.0
Range, Mechanical Index: 1.9
Maximum, or Derated Isppa:
190 W/cm² max	Same
Power
Requirements	Power requirements:
AC :100V- 240V,
Frequenzy:50-60Hz
Operating temperature: 10-40
C; relative humidity 30-
75%;Barometric pressure:700
to 1060 hPa	Power requirements:
AC :100V- 240V,
Frequenzy:50-60Hz
Operating temperature: 10-40°
C; relative humidity 30-
75%;Barometric pressure:700 to
1060 hPa	Same

Table 1 Substantial Equivalence Comparison

36

37

38

SE Analysis 1:

Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in value range or setting. But both of them comply with the requirements of IEC60601-1 & IEC60601-2-37 and meet clinical requirements. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

39

9. Substantially Equivalent Conclusion:

In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, Chison Medical Imaging Co., Ltd. concludes that the EBit Series Diagnostic Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.