CBit Series Digital Color Doppler Ultrasound System

• K Number: K180974
• Device Name: CBit Series Digital Color Doppler Ultrasound System
• Manufacturer: CHISON Medical Technologies Co., Ltd.
• Date Cleared: 2018-08-17 ( 126 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Trans-esophageal,Trans-rectal, Trans-vaginal, OB/GYN and Urology.

Device Description

The CBit Series Digital Color Doppler 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

K170374, K150861

Reference Devices

K150861

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and processing techniques (autocorrelation, FFT) and does not mention AI, ML, or related terms. There is no description of training or test sets, which are typical for AI/ML devices.

Therapeutic

No.
The device is described as a "Color Doppler Ultrasound System" intended for "clinical diagnostic imaging applications," meaning its primary function is to acquire and display imaging data for diagnosis, not for therapeutic intervention.

Diagnostic

Yes

The "Device Description" explicitly states that the system is "intended for clinical diagnostic imaging applications" and is a "color diagnostic ultrasound system." The "Intended Use / Indications for Use" section also lists various evaluations for which the device is used.

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," which are hardware components.

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 the device is for "evaluation of Fetal, Abdominal, Pediatric, Small Organ... and Urology." This describes a device used for imaging and diagnosis within the body, not for testing samples taken from the body.
• Device Description: The description details an "integrated preprogrammed color doppler ultrasound imaging system" that "acquire ultrasound echo data and to display the image." This is consistent with an imaging device, not a device that analyzes biological samples.
• Input Imaging Modality: The input modality is "Ultrasound," which is an imaging technique, not a method for analyzing in vitro samples.
• Anatomical Site: The listed anatomical sites are all locations within the human body that are imaged directly.
• Performance Studies: The performance studies focus on safety aspects like electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output. These are typical evaluations for imaging devices, not IVDs which would require performance studies related to the accuracy of analyzing biological samples.

IVD devices are designed to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information about a physiological state, disease, or congenital abnormality. This device does not perform such analysis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Trans-esophageal,Trans-rectal, Trans-vaginal, OB/GYN and Urology.

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

IYN, IYO, ITX

Device Description

The CBit Series Digital Color Doppler 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, Trans-esophageal, Trans-rectal, Trans-vaginal, OB/GYN, Urology.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

qualified clinician, Hospitals, clinics

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)

The CBit Series Digital Color Doppler 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 Safetv

IEC 60601-1-2: 2014 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

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.

K170374, K150861

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.

K150861

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

CHISON Medical Technologies Co., Ltd. August 17, 2018 % Mr. Liu Qifei Regulatory Affairs Manager No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang Industrial Park Xinwu District, Wuxi, Jiangsu 214142 CHINA

Re: K180974

Trade/Device Name: CBit Series Digital Color Doppler 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 5, 2018 Received: July 9, 2018

Dear Mr. Qifei:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Bollyer

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

Indications for Use

510(k) Number (if known)

K180974

Device Name

CBit Series Digital Color Doppler Ultrasound System

Indications for Use (Describe)

The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Trans-esophageal,Trans-rectal, Trans-vaginal, OB/GYN and 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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3

Diagnostic Ultrasound Indications For Use

System: CBit Series Digital Color Doppler 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	3,4,6,7
	Abdominal	N	N	N		N	N	N	3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	3,5,6,7
	Small Organ[1] (Specify)	N	N	N		N	N	N	3,5,6,7
	Neonatal Cephalic	N	N	N	N	N	N	N	3,6,7,8
	Adult Cephalic	N	N	N	N	N	N	N	3,6,7,8
	Trans-rectal	N	N	N		N	N	N	3,5,6,7
	Trans-vaginal	N	N	N		N	N	N	3,4,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	3,5,6,7
	Other (OB/GYN)	N	N	N		N	N	N	3,5,6,7
	Other (Urology)	N	N	N		N	N	N	3,5,6,7
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	3,6,7,8
	Cardiac Pediatric	N	N	N	N	N	N	N	3,6,7,8
	Transesophageal	N	N	N	N	N	N	N	3,7,8
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	3,5,6,7

P = previously cleared bv FDA: E = added under this appendix N = new indication:

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

4

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D3C60L

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	N	3,6,7
	Abdominal	N	N	N	N	N	N	N	3,5,6,7
	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)	N	N	N	N	N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N	N	N	N	N	3,5,6,7
	Other (Urology)	N	N	N	N	N	N	N	3,5,6,7
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

5

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D5C40L

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	3,6,7
	Abdominal	N	N	N		N	N	N	3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	3,5,6,7
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N		N	N	N	3,5,6,7
	Other (Urology)	N	N	N		N	N	N	3,5,6,7
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

6

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D3C50L

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	N	3,6,7
	Abdominal	N	N	N	N	N	N	N	3,5,6,7
	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)	N	N	N	N	N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N	N	N	N	N	3,5,6,7
	Other (Urology)	N	N	N	N	N	N	N	3,5,6,7
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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

CBit Series Digital Color Doppler Ultrasound System System: Transducer: M3C60L

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	N	3,6,7
	Abdominal	N	N	N	N	N	N	N	3,5,6,7
	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)	N	N	N	N	N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N	N	N	N	N	3,5,6,7
	Other (Urology)	N	N	N	N	N	N	N	3,5,6,7
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

8

CBit Series Digital Color Doppler Ultrasound System System: Transducer: H3C60L

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	3,6,7
	Abdominal	N	N	N		N	N	N	3,5,6,7
	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)	N	N	N		N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N		N	N	N	3,5,6,7
	Other (Urology)	N	N	N		N	N	N	3,5,6,7
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

9

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D7L40L

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	3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	3,5,6,7
	Small Organ[1] (Specify)	N	N	N		N	N	N	3,5,6,7
	Neonatal Cephalic	N	N	N		N	N	N	3,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	3,5,6,7
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

10

System: CBit Series Digital Color Doppler Ultrasound System Transducer: D12L40L

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		Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal	N	N	N	N	N	N	N		3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N		3,5,6,7
	Small Organ[1] (Specify)	N	N	N	N	N	N	N		3,5,6,7
	Neonatal Cephalic	N	N	N	N	N	N	N		3,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N		3,5,6,7
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N		3,5,6,7
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N		3, 5, 6, 7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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: CBit Series Digital Color Doppler Ultrasound System Transducer: M8L40L

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	N	3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	3,5,6,7
	Small Organ[1] (Specify)	N	N	N	N	N	N	N	3,5,6,7
	Neonatal Cephalic	N	N	N	N	N	N	N	3,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	3,5,6,7
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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

CBit Series Digital Color Doppler Ultrasound System System: Transducer: M8L60L

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	N	3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	3,5,6,7
	Small Organ[1] (Specify)	N	N	N	N	N	N	N	3,5,6,7
	Neonatal Cephalic	N	N	N	N	N	N	N	3,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	3,5,6,7
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

13

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D10L30L

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	3,5,6,7
	Small Organ[1] (Specify)	N	N	N	N	N	N	N	3,5,6,7
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	3,5,6,7
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

14

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D8L50L

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	3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	3,5,6,7
	Small Organ1 (Specify)	N	N	N		N	N	N	3,5,6,7
	Neonatal Cephalic	N	N	N		N	N	N	3,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	3,5,6,7
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

15

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D7L40L-REC

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	3,5,6,7
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)
	Other (Urology)	N	N	N		N	N	N	3,5,6,7
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

16

System: CBit Series Digital Color Doppler Ultrasound System Transducer: V6C10L

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	N	N	N		N	N	N	3,5,6,7
	Trans-vaginal	N	N	N		N	N	N	3,4,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N		N	N	N	3,5,6,7
	Other (Urology)	N	N	N		N	N	N	3,5,6,7
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

17

System: CBit Series Digital Color Doppler Ultrasound System Transducer: D6C12L

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 Organ1 (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	N	N	3,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N		N	N	N	3,5,6,7
	Other (Urology)	N	N	N		N	N	N	3,5,6,7
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

18

System: CBit Series Digital Color Doppler Ultrasound System Transducer: D6C10L

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	N	3,5,6,7
	Trans-vaginal	N	N	N	N	N	N	N	3,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N	N	N	N	N	3,5,6,7
	Other (Urology)	N	N	N	N	N	N	N	3,5,6,7
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

19

System: CBit Series Digital Color Doppler Ultrasound System Transducer: D7C10W

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	N	3,5,6,7
	Trans-vaginal	N	N	N	N	N	N	N	3,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N	N	N	N	N	3,5,6,7
	Other (Urology)	N	N	N	N	N	N	N	3,5,6,7
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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

System: CBit Series Digital Color Doppler Ultrasound System Transducer: D7C10L

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	N	3,5,6,7
	Trans-vaginal	N	N	N	N	N	N	N	3,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N	N	N	N	N	3,5,6,7
	Other (Urology)	N	N	N	N	N	N	N	3,5,6,7
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

21

System: CBit Series Digital Color Doppler Ultrasound System Transducer: M7C10L

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	N	N	N	N	N	N	N	3,5,6,7
	Trans-vaginal	N	N	N	N	N	N	N	3,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N		N	N	N	3,5,6,7
	Other (Urology)	N	N	N		N	N	N	3,5,6,7
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

22

System: CBit Series Digital Color Doppler Ultrasound System Transducer: D7BC8

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	N	3,5,6,7
	Trans-vaginal	N	N	N	N	N	N	N	3,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N	N	N	N	N	3,5,6,7
	Other (Urology)	N	N	N	N	N	N	N	3,5,6,7
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

23

System: CBit Series Digital Color Doppler Ultrasound System Transducer: D3C20L

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	3,6,7
	Abdominal	N	N	N		N	N	N	3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	3,5,6,7,8
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	3,5,6,7
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)	N	N	N		N	N	N	3,5,6,7
	Other (Urology)	N	N	N		N	N	N	3,5,6,7
Cardiac	Cardiac Adult	N	N	N		N	N	N	3,6,7,8
	Cardiac Pediatric	N	N	N		N	N	N	3,6,7,8
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	3,5,6,7

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

24

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D6C15L

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	N	3,5,6,7
	Abdominal	N	N	N	N	N	N	N	3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	3,5,6,7,8
	Small Organ1 (Specify)
	Neonatal Cephalic	N	N	N	N	N	N	N	3,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)
	Other (Urology)	N	N	N	N	N	N	N	3,5,6,7
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	N	3,6,7,8
	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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

25

System: CBit Series Digital Color Doppler Ultrasound System Transducer: D5C20L

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	N	3,5,6,7
	Abdominal	N	N	N	N	N	N	N	3,5,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	3,5,6,7,8
	Small Organ1 (Specify)
	Neonatal Cephalic	N	N	N	N	N	N	N	3,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)
	Other (Urology)	N	N	N	N	N	N	N	3,5,6,7
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	3,6,7,8
	Cardiac Pediatric	N	N	N	N	N	N	N	3,6,7,8
	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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D3P64L

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	N	3,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic	N	N	N	N	N	N	N	3,6,7,8
	Adult Cephalic	N	N	N	N	N	N	N	3,6,7,8
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	3,6,7,8
	Cardiac Pediatric	N	N	N	N	N	N	N	3,6,7,8
	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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

27

System: CBit Series Digital Color Doppler Ultrasound System Transducer: D3P64LS

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	N	N	N	N	N	N	N	3,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic	N	N	N	N	N	N	N	3,6,7,8
	Adult Cephalic	N	N	N	N	N	N	N	3,6,7,8
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	3,6,7,8
	Cardiac Pediatric	N	N	N	N	N	N	N	3,6,7,8
	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/PD, 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

4.4D

• 5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

28

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D2P64L

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	N	3,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic	N	N	N	N	N	N	N	3,6,7,8
	Adult Cephalic	N	N	N	N	N	N	N	3,6,7,8
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	3,6,7,8
	Cardiac Pediatric	N	N	N	N	N	N	N	3,6,7,8
	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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D5P64L

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	3,6,7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	3,6,7,8
	Small Organ[1] (Specify)
	Neonatal Cephalic	N	N	N	N	N	N	N	3,6,7,8
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Other (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	N	3,6,7,8
	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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

30

CBit Series Digital Color Doppler Ultrasound System System: Transducer: D2D16L

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 (OB/GYN)
	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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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

CBit Series Digital Color Doppler Ultrasound System System: Transducer: V4C40L

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	N	3,4,7
	Abdominal	N	N	N	N	N	N	N	3,4,7
	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 (OB/GYN)	N	N	N	N	N	N	N	3,4,7
	Other (Urology)	N	N	N	N	N	N	N	3,4,7
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

32

System: CBit Series Digital Color Doppler Ultrasound System Transducer: T5P64L

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 (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal	N	N	N	N	N	N	N	3,7,8
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	3,7,8

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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

CHISON Medical Technologies Co., Ltd. System: CBit Series Digital Color Doppler Ultrasound System Transducer: MT5P48L

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

Clinical Application		Mode of Operation
General	Specific	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Other
(Track 1 Only)	(Tracks 1 & 3)
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 (OB/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
Cardiac	Cardiac Pediatric
	Transesophageal	N	N	N	N	N	N	N	3,7,8
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/PD, 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

4.4D

5. Elastography

6. Includes guidance of biopsy (2D)

7. Fusion Harmonic Imaging

8.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)

34

510(k) Summary

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

1. Submitter:

Submitter:	CHISON Medical Technologies Co., Ltd.
Address:	No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang
	Industrial Park, Xinwu District, Wuxi, Jiangsu, China 214142
	No.9, Xinhuihuan Road, Xinwu District, Wuxi, Jiangsu, China 214028
Contact:	Mr. Liu Qifei
Tel:	[phone]
Fax:	[phone]
Date Prepared:	March 29, 2018

2. Device :

Trade Name: CBit Series Digital Color Doppler Ultrasound System

Common Name: Diagnostic Ultrasound System with Transducers

Classification: Regulatory Class: II Review Category: Tier II

Classfication 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):

Device	Manufacturer	Model	510(k)Number
1.Main predicate device	CHISON	SonoBook 9	K170374
2.Reference device	CHISON	QBit 9	K150861

4. Device Description:

The CBit Series Digital Color Doppler 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,

35

Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

5. Indications for Use:

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic ,Adult Cephalic, Cardiac (adult , pediatric), Musculo -skeletal (Conventional, Superficial),Peripheral Vascular, Trans-esophageal, Trans-rectal,Trans-vaginal, OB/GYN and Urology.

6. Summary of Non-Clinical Tests:

The CBit Series Digital Color Doppler 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 Safetv

IEC 60601-1-2: 2014 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.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005", is also included as part of this submission.

8. Comparison to Predicate Device:

Items	Main predicate device	Reference device	Submission Device	Remark
	SonoBook 9 Diagnostic
Ultrasound System
K170374.	QBit 9 Diagnostic
Ultrasound System
K150861	CBit Series Digital
Color Doppler
Ultrasound System
Indications for Use	Fetal
Abdominal	Fetal
Abdominal	Fetal
Abdominal	SE
Analysis 1
	Main predicate device	Reference device	Submission Device
Items	SonoBook 9 Diagnostic
Ultrasound System
K170374.	QBit 9 Diagnostic
Ultrasound System
K150861	CBit Series Digital
Color Doppler
Ultrasound System	Remark
	Pediatric	Pediatric	Pediatric
	Small Organ (breast,
thyroid ,testes)	Small Organ (breast,
thyroid ,testes)	Small Organ (breast,
thyroid ,testes)
	Neonatal Cephalic ,Adult	Neonatal	Neonatal
	Cephalic	Cephalic ,Adult	Cephalic ,Adult
	Trans-rectal	Cephalic	Cephalic
	Trans-vaginal	Trans-rectal	Trans-rectal
	Musculo-skeletal( Convent
ional, Superficial)	Trans-vaginal	Trans-vaginal
	Cardiac(adult ,pediatric)	Musculo-skeletal( Con
ventional, Superficial)	Musculo-skeletal( Conv
entional, Superficial)
	Peripheral Vascular	Cardiac(adult ,pediatri
c)	Cardiac(adult ,pediatric)
	Urology	Peripheral Vascular	Peripheral Vascular
OB/GYN,Urology
	Trans-esophageal	Urology	Trans-esophageal
		Trans-esophageal
	Autocorrelation for color
processing and FFT for
pulseand CW Doppler
processing.	Autocorrelation for
color processing and
FFT for pulse and CW
Doppler processing.	Autocorrelation for color
processing and FFT for
pulse and CW Doppler
processing.
Design	Supporting Linear,
Curve,Phase array and
Volumeprobes.	Supporting Linear,
Curve , Phase array
and Volume probes .	Supporting Linear,
Curve , Phase array and
Volume probes .	Same
	Cine play back capability
Image file archive	Cine play back
capability
Image file archive	Cine play back
capability
Image file archive
	TGC 8 slider	TGC 8 slider	TGC 8 slider	Same
	Depth Range: 0 to 30 cm	Depth Range: 0 to 30
cm	Depth Range: 0 to 45
cm	SE
Analysis 2
	256 shades of gray	256 shades of gray	256 shades of gray	Same
	B Dynamic range control:
60-165 dB, 7/step	B Dynamic range
control: 30-180 dB,
5/step	B Dynamic range
control: 20-280dB	SE
Analysis 2
	Gain:0-255,1/step	Gain:0-255,1/step	Gain:0-255,1/step	Same
	Focal Number: adjustable	Focal Number:
adjustable	Focal Number:
adjustable	Same
Operating
Controls	Focus position: adjustable	Focus position:
adjustable	Focus position:
adjustable	Same
	B steer: available on linear
transducers	B steer: available on
linear transducers	B steer: available on
linear transducers	Same
	B Persistence: 7 steps	B Persistence: 7 steps	B Persistence: 7 steps	Same
	ROI size/position:
adjustable	ROI size/position:
adjustable	ROI size/position:
adjustable	Same
	Color Wall Filter settings:4
steps	Color Wall Filter
settings:8 steps	Color Wall Filter
settings:8 steps	Same
	Color Baseline: 7 steps	Color Baseline: 16
steps	Color Baseline: 16
steps	Same
	Main predicate device	Reference device	Submission Device
Items	SonoBook 9 Diagnostic
Ultrasound System	QBit 9 Diagnostic
Ultrasound System	CBit Series Digital
Color Doppler
Ultrasound System	Remark
	K170374.	K150861
	Color Invert: on/off	Color Invert: on/off	Color Invert: on/off	Same
	PW sweeping speed:
3steps	PW sweeping speed:
6 steps	PW sweeping speed: 6
steps	Same
	PW Wall Filter: 4 steps	PW Wall Filter: 7 steps	PW Wall Filter: 7 steps	Same
	PW sample volume:
1-8mm (PW only), 8 steps	PW sample volume:
0.5-30mm (PW only),
13 steps	PW sample volume:
0.5-30mm (PW only)	Same
	PW angle
correction:-80~80degrees,
5/step	PW angle
correction:-89~89degrees, 1/step	PW angle
correction:-89~89degrees,1/step	Same
	Baseline: 7steps	Baseline: 8steps	Baseline: 8steps	Same
	Cine control: step, play
backward, play
continuously	Cine control: step, play backward, play
continuously	Cine control: step, play
backward, play
continuously	Same
	Doppler Auto Trace	Doppler Auto Trace	Doppler Auto Trace	Same
	Freeze control:Toggling
freeze key	Freeze control:Toggling
freeze key	Freeze control:Toggling
freeze key	Same
	IEC60601-1	IEC60601-1	IEC60601-1
	IEC60601-1-2	IEC60601-1-2	IEC60601-1-2
Safety
Compliance	ISO 10993-1	ISO 10993-1	ISO 10993-1
	ISO 10993-5	ISO 10993-5	ISO 10993-5	Same
	ISO 10993-10	ISO 10993-10	ISO 10993-10
	AIUM/ NEMA UD2	AIUM/ NEMA UD2	AIUM/ NEMA UD2
	AIUM/ NEMA UD3	AIUM/ NEMA UD3	AIUM/ NEMA UD3
Operation
Mode	B mode	B mode	B mode	Same
	B/M mode	B/M mode	B/M mode	Same
	M mode	M mode	M mode	Same
	Dual mode	Dual mode	Dual mode	Same
	Quad mode	Quad mode	Quad mode	Same
	CFM mode	CFM mode	CFM mode	Same
	CPA mode	PD mode	CPA mode	Same
	DPD mode	DPD mode	DPD mode	Same
	PW mode	PW mode	PW mode	Same
	B/BC mode	B/BC mode	B/BC mode	Same
	2D Steer	2D Steer	2D Steer	Same
	Triplex mode	Triplex	Triplex mode	Same
	Quadplex	Quadplex	Quadplex	Same
	Free Hand 3D	--	HD 3D	Same
	CW mode	CW mode	CW mode	Same
	Free Steering M mode	Free Steering M mode	Free Steering M mode	Same
	HPRF	HPRF	HPRF	Same
	B-Flow	--	S-flow	Same
	AutoTGC	--	Auto TGC	Same
	Stress Echo	--	Stress echo	Same
	Strain	--	Strain	Same
Items	Main predicate device	Reference device	Submission Device	Remark
	SonoBook 9 Diagnostic
Ultrasound System
K170374.	QBit 9 Diagnostic
Ultrasound System
K150861	CBit Series Digital
Color Doppler
Ultrasound System
	TDI	TDI	TDI	Same
	Color M mode	Color M mode	Color M mode	Same
	Curved Panoramic	Curved Panoramic	Curved Panoramic	Same
	Trapezoidal mode	Trapezoidal image	Trapezoidal image	Same
	Compound	compound	compound	Same
	SRA	SRA	SRA	Same
	Chroma	Chroma	Chroma	Same
	Elastography	Elastography	Elastography	Same
	ECG	ECG	ECG	Same
	--	--	LV tracking	SE
Analysis 3
	--	--	LGC	SE
Analysis 4
	Auto IMT	Auto IMT	Auto IMT	Same
	Auto NT	---	Free NT	Same
	Super Needle	Super Needle	Super Needle	Same
	General measurement
package	general measurement
package	general measurement
package	Same
	OB measurement package	OB measurement
package	OB measurement
package	Same
	GYN measurement
package	GYN measurement
package	GYN measurement
package	Same
	URO measurement
package	URO measurement
package	URO measurement
package	Same
	Cardiac measurement
package	cardiac measurement
package	cardiac measurement
package	Same
	Vascular measurement
package	vascular measurement
package	vascular measurement
package	Same
	Small parts measurement
package	small parts measurement
package	small parts measurement
package	Same
	Pediatric measurement
package	Pediatric measurement
package	Pediatric measurement
package	Same
	TCD measurement
package	--	TCD measurement
package	Same
	4D software package	4D software package	4D software package	Same
	--	--	Breast measurement
package	SE
Analysis 5
	Virtual HD	Virtual HD	Virtual HD	Same
	X-Contrast	X-Contrast	X-Contrast	Same
	FHI	FHI	FHI	Same
	Q-Image	Q-image	Q-image	Same
	Q-flow	Q-flow	Q-flow	Same
	Q-beam	Q-beam	Q-beam	Same
	AIO	AIO	AIO	Same
	Main predicate device	Reference device	Submission Device
Items	SonoBook 9 Diagnostic
Ultrasound
System
K170374.	QBit 9 Diagnostic
Ultrasound System
K150861	CBit Series
Digital
Color
Doppler
Ultrasound System	Remark
Display
Annotations	Logo;
Hospital
Name;Exam date;Exam
time;
Acoustic
Power
;Mechanical
index;Tissue
thermal
name,First
indes;ID,Last
Name,Middle
initial, Gender, Age; Probe
model;ECG
ico;Operator;TGC
Corve;Focus
position;Thumbnail;Imagin
parameters;Dynamic
Trackball indices	Logo;
Hospital
Name;Exam
date;Exam
time;
Acoustic
;Mechanical
Power
index;Thermal
indes;Probe
model;ECG ico;TGC
Corve;Focus
position;Imaging
parameters;Dynamic
Trackball
indices;
System
status;Gray/Color bar	Logo;
Hospital
Name;Exam date;Exam
time;
Acoustic
Power
;Mechanical
index;Thermal
indes; Probe
ico;TGC
model; ECG
Corve;Focus
position;Imaging
parameters;Dynamic
indices;
Trackball
System
status;Gray/Color bar	Same
Measurements	2D mode:
Depth
Distance ,Area: Ellipse,
Trace, Spline
Trace, Trace,
Length , Volume :Distance,
Ellipse, Ellipse + Distance,
Distance Ratio ,Area
Ratio , IMT, Volume Flow,
M mode: Distance,Time,
Heart Rate,Velocity;
Doppler mode:
D
Velocity , Time , Heart
Rate,Acceleration ,D
Trace,PS/ED , Volume
Flow;	2D mode: Depth
Distance ,Area:
Ellipse, Trace, Spline,
Cross,Trace Length ,
Double Distance
Parallel ,Volume :Dist
ance, 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, Spline, Trace
Length , Double
Distance
Parallel ,Volume :Distan
ce, Ellipse, Ellipse +
Distance, Distance
Ratio ,Area Ratio , IMT,
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
1 ports	Convex Array,
Phased Array, Linear
Array,Volume probe
4ports	Convex Array, Phased
Array, Linear
Array,Volume probe
4ports	Same
Users / Sites	Hospitals, clinics usage	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,	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	Same
Items	Main predicate device	Reference device	Submission Device	Remark
	SonoBook 9 Diagnostic
Ultrasound System
K170374.	QBit 9 Diagnostic
Ultrasound System
K150861
or Derated Isppa: 190 W/cm² max	CBit Series Digital
Color Doppler
Ultrasound System
W/cm² max
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	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

39

40

Comparison Analysis

SE Analysis 1:

Indication for use, compared with the predicate device, the subject device has some differences in presenting OB/GYN.

OB/GYN is short for obstetrics/gynecology. Both predicate and subject device contain OB measurement package and GYN measurement package. OB/GYN application can be seen as part of Fetal, Abdominal and Trans-vaginal applications in some degree. Both of the predicate and subject device 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.

SE Analvsis 2:

Operation mode, compared with the predicate device, the subject device employs the same operation controls design and has some differences in value range. 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.

SE Analysis 3:

Operation mode, compared with the predicate device, the subject device employs the same operation controls design and has some differences in presenting LV tracking. LV tracking is a non-invasive method for the assessment of left ventricular(LV) function. The relevant measurement items are IVSd, LVPWd, IVSs, LVIDs, LVPWs, LVLd, LVLs, LVAMd, LVAMs, LVAPs, EDV and ESV, of which are all under cardiac measurement 510(k) Summary Page 7 of 8

41

package. Both predicate and submission device contain cardiac measurement package. Both of the predicate and subject device 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.

SE Analysis 4:

Operation mode, compared with the predicate device, the subject device employs the same operation controls design and has some differences in presenting LGC. LGC (Lateral Gain Compensation) consists of the same tabular array as TGC, which is contained in predicate and submission device. The only difference is that the array is arranged horizontally by LGC while vertically by TGC. The goal of LGC is to have control over the image brightness from side to side.

Both of the predicate and subject device 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.

SE Analysis 5:

Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in presenting Breast measurement package. Breast measurement is under the small parts measurement package in B mode, including length, height, width and volume measurement items. Both predicate and submission device contain small parts (breast, thyroid, testes) measurement package.

Both of the predicate and subject device 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.

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 Technologies Co., Ltd. concludes that the CBit Series Digital Color Doppler Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.