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
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K153085
• Predicate For: K223570

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.

AI/ML Overview

I am sorry, but the provided text is a 510(k) Pre-Market Notification for a Diagnostic Ultrasound System and does not contain the specific details about acceptance criteria, device performance, study designs (sample sizes, provenance, ground truth, expert qualifications, adjudication methods), MRMC comparative effectiveness studies, or standalone algorithm performance that you requested.

The document primarily focuses on:

• Indications for Use: Listing the clinical applications for which the device is intended.
• Safety and Performance Standards: Stating that the device conforms to various IEC, NEMA, and ISO standards related to electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output.
• Comparison to Predicate Device: Highlighting similarities in features, operating controls, display modes, and safety compliance with a previously cleared device (Q Series Diagnostic Ultrasound System K153085).
• Conclusion: Asserting substantial equivalence to predicate devices based on safety and effectiveness.

It explicitly states: "No clinical testing was required." This means there wasn't a study of the type you are asking about, designed to assess the device's diagnostic performance against a ground truth or compared to human readers. The substantial equivalence was established based on engineering and safety testing, and comparison of technical specifications to a predicate device.

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.

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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

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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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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)

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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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CW	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PowerDoppler Doppler Doppler Doppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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 DiagnosticUltrasound SystemK150861	EBit Series DiagnosticUltrasound System	Remark
Indications forUse	FetalAbdominalPediatricSmall Organ (breast, thyroid, testes)Neonatal Cephalic, AdultCephalic	FetalAbdominalPediatricSmall Organ (breast, thyroid, testes)Neonatal Cephalic, AdultCephalic, Transrectal,	Same
	Predicate Device	Submission Device
Product Name(K number)	Q Series DiagnosticUltrasound SystemK150861	EBit Series DiagnosticUltrasound System	Remark
	Transrectal, Transvaginal,Musculo-skeletal(Conventional, Superficial)Cardiac(adult, pediatric)Peripheral VascularUrologyTransesophageal	Transvaginal,Musculo-skeletal (Conventional,Superficial)Cardiac(adult, pediatric)Peripheral VascularUrologyTransesophageal
Design	Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting: Linear, Curve,Phase array and Volumeprobes.Cine play back capabilityImage file archive	Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting Linear, Curve,Phase array and Volumeprobes.Cine play back capabilityImage 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	SEAnalysis 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 lineartransducers	B steer: available on lineartransducers	Same
	B Persistence: 7 steps	B Persistence: 7 steps	Same
	ROI size/position: adjustable	ROI size/position: adjustable	Same
	Color Wall Filter settings:8steps	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, playbackward, play continuously	Cine control: step, playbackward, play continuously	Same
	Doppler Auto Trace	Doppler Auto Trace	Same
	Freeze control: Toggling freezekey	Freeze control: Toggling freezekey	Same
	Predicate Device	Submission Device
Product Name(K number)	Q Series DiagnosticUltrasound SystemK150861	EBit Series DiagnosticUltrasound System	Remark
SafetyCompliance	IEC60601-1 Medical electricalequipment - Part 1: Generalrequirements for safetyIEC60601-1-2 Medicalelectrical equipment - Part 1-2:General requirements forsafety - Collateral standard:Electromagnetic compatibility -Requirements and testsIEC60601-2-37 Medicalelectrical equipment - Part 2-37: Particular requirements forthe safety of ultrasonic medicaldiagnostic and monitoringequipmentISO 10993-1 Biologicalevaluation of medical devices -Part 1: Evaluation and testingwithin a risk managementprocess	IEC60601-1 Medical electricalequipment - Part 1: Generalrequirements for safetyIEC60601-1-2 Medical electricalequipment - Part 1-2: Generalrequirements for safety -Collateral standard:Electromagnetic compatibility -Requirements and testsIEC60601-2-37 Medicalelectrical equipment - Part 2-37:Particular requirements for thesafety of ultrasonic medicaldiagnostic and monitoringequipmentISO 10993-1 Biologicalevaluation of medical devices -Part 1: Evaluation and testingwithin a risk managementprocess	Same
	Operation Mode B, THI, M, Color M, FreeSteering M mode, ColorDoppler Imaging, PowerDoppler Imaging / DirectionalPD, Pulsed Wave Doppler,Continuous Wave Doppler,TDI, Contrast Imaging, 3D/ 4D,Elastography, CurvedPanoramic, Trapezoidal image	B, THI, M, Color M, FreeSteering M mode, Color DopplerImaging, Power DopplerImaging / Directional PD,Pulsed Wave Doppler,Continuous Wave Doppler, TDI,Contrast Imaging, 3D/ 4D,Elastography, CurvedPanoramic, 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/DirPower, TDI, 3D/4D;B+M, B+PW, B+CFM,B+PD/DPD, B+CFM+PW/CW,B+PW+PD/DPD	Same
DisplayAnnotations	Logo; Hospital Name; Examdate; Exam time; AcousticPower; Mechanical index;Tissue thermal indes; ID, Lastname, First Name, Middleinitial, Gender, Age; Probemodel; ECG ico; Operator;TGC Curve; Focus position;Thumbnail; Imagingparameters; Dynamic Trackballindices	Logo; Hospital Name; Examdate; Exam time; AcousticPower; Mechanical index;Tissue thermal indes; ID, Lastname, First Name, Middle initial,Gender, Age; Probe model;ECG ico; Operator; TGC Curve;Focus position; Thumbnail;Imaging parameters; DynamicTrackball indices	Same
	Predicate Device	Submission Device
Product Name(K number)	Q Series DiagnosticUltrasound SystemK150861	EBit Series DiagnosticUltrasound System	Remark
Display Monitor	15"high-resolution color LCDmonitor	15" high-resolution color LCDmonitor	Same
Measurements	2D mode: Depth, Distance,Area: Ellipse, Trace, Spine,Cross, Trace Length, DoubleDistance, Parallel, VolumeDistance, Ellipse, Ellipse +Distance, Length Ratio, AreaRatio , IMT, B Histogram, BProfile, Volume Flow, ColorVelocity;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, DoubleDistance, Parallel, VolumeDistance, Ellipse, Ellipse +Distance, Length Ratio, AreaRatio , IMT, B Histogram, BProfile, Volume Flow, ColorVelocity;M mode: Distance, Time, Slope,Heart Rate, Velocity;Doppler mode: D Velocity ,Time,Heart Rate, Acceleration, DTrace, PS/ED, Volume Flow;	Same
TransducerTypes &Connectors	Convex Array, Phased Array,Linear Array, Volume probe2ports	Convex Array, Phased Array,Linear Array, Volume probe2ports	Same
Users / Sites	Hospitals, clinics usage	Hospitals, clinics usage	Same
Acoustic Output	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm²maximum, TIS/TIB/TIC:0.1-4.0Range, Mechanical Index: 1.9Maximum, or Derated Isppa:190 W/cm² max	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm²maximum, TIS/TIB/TIC:0.1-4.0Range, Mechanical Index: 1.9Maximum, or Derated Isppa:190 W/cm² max	Same
PowerRequirements	Power requirements:AC :100V- 240V,Frequenzy:50-60HzOperating temperature: 10-40C; relative humidity 30-75%;Barometric pressure:700to 1060 hPa	Power requirements:AC :100V- 240V,Frequenzy:50-60HzOperating temperature: 10-40°C; relative humidity 30-75%;Barometric pressure:700 to1060 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.

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.