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,Transectal, Transvaginal, Urology.

Device Description

The QBit 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

The provided document is a 510(k) premarket notification for the CHISON Medical Imaging Co., Ltd. QBit Series Diagnostic Ultrasound System. This document asserts substantial equivalence to a predicate device and does not present an independent clinical study with acceptance criteria and device performance metrics in the way a clinical trial report would.

Instead, the document focuses on demonstrating that the QBit Series Diagnostic Ultrasound System has similar technological characteristics and performance to a legally marketed predicate device (DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System, K132341), thereby concluding that it is as safe and effective.

Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth for a de novo or novel device cannot be directly extracted from this type of regulatory submission in the typical sense. However, I can infer and extract information to the best of my ability based on the provided text, primarily from the "Comparison to Predicate Device" table.

Here's the breakdown of what can be gathered and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical task. Instead, it relies on demonstrating that the "Submission Device" (QBit Series) is comparable to the "Predicate Device" in terms of indications for use, design, operating controls, safety compliance, patient contact materials, operation modes, display modes, display annotations, display monitor, measurements, transducer types & connectors, acoustic output, and power requirements.

The "reported device performance" is essentially the statement that the submission device is "Same" or "Substantially Equivalent" (SE) to the predicate across these many features.

Feature	Acceptance Criteria (Implied: "Same as Predicate")	Reported Device Performance (Submission Device)	Remark
Indications for Use	Same as Predicate	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.	Same
Design	Same as Predicate	Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve, Phase array and Volume probes. Cine play back capability. Image file archive.	Same
Operating Controls	Equivalent to Predicate	TGC 8 slider. Depth Range: 0 to 30 cm (Predicate: 1.5 to 40 cm). 256 shades of gray. B Dynamic range control: 30-180 dB, 5/step. Gain: 0-255, 1/step (Predicate: 0-100, 1/step). Focal Number: 1-4. Focus position: adjustable. B steer: available on linear transducers. B Persistence: 7 steps. ROI size/position: adjustable. Color Wall Filter settings: 8 steps. Color Baseline: 16 steps. Color Maps: 21 maps. Color Invert: on/off. PW sweeping speed: 6 steps. PW Wall Filter: 7 steps. PW sample volume: 0.5-30mm (PW only), 13 steps. PW angle correction: -89~89degrees, 1/step. Baseline: 8 steps.	SE Analysis 1 (Depth Range, Gain differences considered SE)
Safety Compliance	Same standards as Predicate	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD3: 2004, ISO 10993-1.	Same
Patient Contact Materials	Biocompatible	Bio-compatible	Same
Operation Mode	Same modes as Predicate	B, FHI, M, Color M, Free M mode, Color Doppler Imaging, Power Continuous Wave Doppler, TDI, Contrast Imaging, 3D/4D, Elastography, Curved. (Predicate lists similar modes including THI, PSH, Steering Free Xros MTM, Free Xros CM, ColorPD, Pulsed Wave Doppler, Doppler Imaging, Power Doppler Imaging/Directional PD, Pulsed Wave Doppler, Continuous Wave Doppler, TDI, UWN+Panoramic, Trapezoidal image, Contrast Imaging, 3D/4D, Elastography, iScape View).	Same
Display Modes	Same modes as Predicate	B,M,PW,CW,CFM,Power/Dirpower,TDI,3D/4D; B+M,B+PW,B+CFM,B+PD/DP D,B+CFM+PW/CW,B+PW+PD/DBD. (Predicate lists identical modes: 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/DP D)	Same
Display Annotations	Same as Predicate	Logo; Hospital Name; Exam date; Exam time; Acoustic Power; Mechanical thermal indes; ID, Last name, First Name, Middle initial, Gender, Age; Probe model; ECG ico; Operator; TGC Corve; Focus position; Thumbnail; Imaging parameters; Dynamic Trackball indices.	Same
Display Monitor	Equivalent to Predicate	15"/ 19" high-resolution color LCD monitor (Predicate: 19" high-resolution color LCD monitor).	Same
Measurements	Same as Predicate	2D mode: Depth, Distance, Area (Ellipse, Trace, Spline, Trace Length, Double Distance, Parallel), Volume (Distance, 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	Same as Predicate	Convex Array, Phased Array, Linear Array, Volume probe. 4 ports.	Same
Acoustic Output	Same as Predicate	Track 3; MI, TIS, TIC, TIB. Derated Ispta: 720mW/cm² maximum, TIS/TIB/TIC: 0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max.	Same
Power Requirements	Equivalent or improved relative to Predicate	AC :100V- 240V, Frequenzy: 50-60Hz, Operating temperature: 10-40° C; relative humidity 30-75%; Barometric pressure:700 to 1060 hPa. (Predicate: AC: 100-127V, or 220-240v, Frequenzy: 50/60 Hz, Operating temperature: 0-40° C; relative humidity 30-85%; Barometric pressure:700 to 1060 hPa).	SE Analysis 2 (Power supply compliance with IEC60601-1 and US voltage range)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This information is not applicable and not provided. The submission states, "No clinical testing was required." The comparison is based on technical specifications and regulatory compliance, not on clinical performance data gathered from a test set of patient cases.
Data Provenance: Not applicable, as no clinical test data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test data with expert-established ground truth is presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test data requiring adjudication is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) submission for a diagnostic ultrasound system, not an AI or CAD (Computer-Aided Detection/Diagnosis) device for which MRMC studies are typically conducted to evaluate reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a diagnostic ultrasound system, the performance of which is inherent to its image acquisition and processing capabilities, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical test data with ground truth is presented. The "ground truth" for this regulatory submission is effectively the compliance with recognized standards (e.g., IEC, NEMA, ISO) and the technical specifications of the predicate device.

8. The sample size for the training set

Not applicable. This document pertains to the regulatory clearance of a medical device based on substantial equivalence, not the development or training of an algorithm using a dataset.

9. How the ground truth for the training set was established

Not applicable.

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 an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

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

July 28, 2015

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

Re: K150861

Trade/Device Name: OBit 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: June 11, 2015 Received: June 30, 2015

Dear Mr. Leiker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Michael D'Hara

For

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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K150861

Device Name QBit Series Diagnostic Ultrasound System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Diagnostic Ultrasound Indications For Use

System: QBit 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 Organ1 (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 R+PWD or CWD or CWD B/Color PWD or CWD B/Power/PWD

Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/ 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

Includes guidance of biopsy(2D)

6.Fusion Harmonic Imaging

7.TDI

Prescription Use × AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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}------------------------------------------------

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 Organ1 (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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

Includes guidance of biopsy(2D)

6.Fusion Harmonic Imaging

7.TDI

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

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

{5}------------------------------------------------

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 Organ1 (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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{6}------------------------------------------------

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 Organ1 (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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{7}------------------------------------------------

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

N = new indication;

P = previously cleared by FDA;

E = added under this appendix

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{8}------------------------------------------------

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 Organ1 (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

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

E = added under this appendix

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{9}------------------------------------------------

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PW Doppler	CW Doppler	Color Doppler	Power Doppler	Combined Modes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ1 (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

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

E = added under this appendix

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{10}------------------------------------------------

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 OrganII (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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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}------------------------------------------------

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 Organ1 (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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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}------------------------------------------------

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PW Doppler	CW Doppler	Color Doppler	Power Doppler	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 Organ1 (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

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

E = added under this appendix

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D
4.Elastography

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}------------------------------------------------

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	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

N = new indication;

P = previously cleared by FDA;

E = added under this appendix

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

Includes guidance of biopsy(2D)

6.Fusion Harmonic Imaging

7.TDI

Prescription Use メ 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}------------------------------------------------

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 Organ1 (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; E = added under this appendix N = new indication;

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{15}------------------------------------------------

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 Organ1 (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; E = added under this appendix N = new indication;

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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}------------------------------------------------

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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{17}------------------------------------------------

Clinical Application		Mode of Operation
General	Specific	B	M	PW	CW	Color	Power	Combined	Other
(Track 1 Only)	(Tracks 1 & 3)						Doppler Doppler Doppler Doppler	Modes
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ111 (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; E = added under this appendix N = new indication;

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{18}------------------------------------------------

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; E = added under this appendix N = new indication;

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{19}------------------------------------------------

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PW Doppler	CW Doppler	Color Doppler	Power Doppler	CombinedModes	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	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; E = added under this appendix N = new indication;

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{20}------------------------------------------------

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 Organ1 (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	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	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{21}------------------------------------------------

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	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	4,5,6
	Small Organ1 (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	N	5,6
	Cardiac Pediatric	N	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+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{22}------------------------------------------------

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 Organ1 (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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{23}------------------------------------------------

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PW	CWDoppler Doppler Doppler Doppler	Color	Power	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal	N	N	Z		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 (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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{24}------------------------------------------------

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 OrganII (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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{25}------------------------------------------------

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

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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}------------------------------------------------

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 OrganII (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+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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}------------------------------------------------

Clinical Application		Mode of Operation
General	Specific	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small OrganII (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 Adult				N
Cardiac Pediatric				N
Transesophageal
Peripheral Vessel	Peripheral vessel				N

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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}------------------------------------------------

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	3,6
	Abdominal	N	N	N		N	N	N	3,4,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ1 (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	6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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)

{29}------------------------------------------------

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 OrganII (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; E = added under this appendix N = new indication;

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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}------------------------------------------------

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 OrganII (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; E = added under this appendix N = new indication;

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast

3.3D/4D

4.Elastography

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}------------------------------------------------

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, ShuoFang, New District,Wuxi 214142, ChinaNo.9 Xin Hui Huan Road, New District ,WuXi P.R.China
Contact:	Ms. Ruoli Mo
Tel:	+86-510-85311707, 85310593
Fax:	+86-510-85310726
Date Prepared:	February 16, 2015

2. Device :

QBit Series Diagnostic Ultrasound System Trade Name:

Common Name: Diagnostic Ultrasound System with Accessories

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):

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

510(k) Number: K132341

4. Device Description:

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)

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Doppler Mode, Color Doppler Mode, Power Doppler Mode, 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 physician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic ,Adult Cephalic,Cardiac (adult , pediatric),Musculo-skeletal Superficial) (Conventional ,Peripheral Vascular,Transesophageal,Transrectal, Transvaginal, Urology.

6. Summary of Non-Clinical Tests:

The QBit 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
ProductName(K number)	DC-8/DC-8 PRO/DC-8 CV/DC-8EXP/DC-8SK132341	QBit SeriesTBD	Remark
Indicationsfor Use	FetalAbdominalPediatricSmall Organ (breast, thyroid, testes)Neonatal Cephalic	FetalAbdominalPediatricSmall Organ (breast, thyroid, testes)	Same
	Predicate Device	Submission Device
ProductName(K number)	DC-8/DC-8 PRO/DC-8 CV/DC-8EXP/DC-8SK132341	QBit SeriesTBD	Remark
	Adult Cephalic	Neonatal Cephalic ,Adult
	Trans-rectal	Cephalic
	Trans-vaginal	Transrectal
	Musculo-skeletal( Conventional,Superficial)	Transvaginal
	adult Cardiac ,pediatric Cardiac)	Musculo-skeletal(Conventional, Superficial)
	Peripheral Vascular ;	Cardiac(adult ,pediatric)
	Urology	Peripheral Vascular
	Transesophageal(Cardiac)	Urology
		Transesophageal
Design	Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting Linear, CurvePhase array and Volume probes	Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting Linear, Curve ,Phase array and Volume probes .	Same
	Cine play back capability	Cine play back capability
	Image file archive	Image file archive
OperatingControls	TGC 8 slider	TGC 8 slider	Same
	Depth Range: 1.5 to 40 cm	Depth Range: 0 to 30 cm	SEAnalysis1
	256 shades of gray	256 shades of gray	Same
	B Dynamic range control:180 dB, 5/step	30-B Dynamic range control: 30-180 dB, 5/step	Same
	Gain:0-100,1/step	Gain:0-255,1/step	SEAnalysis1
	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:8 steps	Color Wall Filter settings:8 steps	Same
	Color Baseline: 16 steps	Color Baseline: 16 steps	Same
	Color Maps: 21 maps	Color Maps: 21 maps	Same
	Color Invert: on/off	Color Invert: on/off	Same
	PW sweeping speed: 6 steps	PW sweeping speed: 6 steps	Same
	PW Wall Filter: 7 steps	PW Wall Filter: 7 steps	Same
	PW sample volume: 0.5-30mm(PW only), 13 steps	PW sample volume: 0.5-30mm (PW only), 13 steps	Same
	PW angle correction:-89~89degrees, 1/step	PW angle correction:-89~89degrees, 1/step	Same
	Baseline: 8steps	Baseline: 8steps	Same
	Predicate Device	Submission Device
ProductName(K number)	DC-8/DC-8 PRO/DC-8 CV/DC-8EXP/DC-8SK132341	QBit SeriesTBD
	Cine control: step, playbackward, play continuouslyDoppler Auto Trace	Cine control: step, playbackward, play continuouslyDoppler Auto Trace	Same
	Freeze control:Toggling freezekey	Freeze control:Toggling freezekey	Same
SafetyCompliance	IEC60601-1 Medical electricalequipment - Part 1: Generalrequirements for safetyIEC60601-1-2 Medical electricalequipment - Part 1-2: Generalrequirements for safetyCollateral 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 testing-within a risk managementprocess	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 ultrasonicmedical diagnostic andmonitoring equipmentISO 10993-1 Biologicalevaluation of medical devices- Part 1: Evaluation andtesting within a riskmanagement process	Same
PatientContactMaterials	Bio-compatible	Bio-compatible	Same
OperationMode	B, THI, PSH (Phase ShiftHarmonic Imaging) , M,Color M,SteeringFree Xros MTM (Anatomical M-Dopplermode), Free Xros CM (Curved DopplerAnatomical M-mode), ColorPD, Pulsed Wave Doppler,Doppler Imaging,Power DopplerImaging/Directional PD, PulsedWave Doppler, ContinuousWave Doppler , TDI, UWN+Panoramic ,Trapezoidal image(Ultra Wideband Non-linear)Contrast Imaging, 3D/ 4DElastography, iScape View(Panoramic Imaging )	B, FHI, M,Color M, FreeM mode , ColorDoppler Imaging,PowerContinuous Wave Doppler ,TDI, Contrast Imaging, 3D/4D ,Elastography, Curved	Same
DisplayModes	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/DP D	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/DBD	Same
	Predicate Device	Submission Device
ProductName(K number)	DC-8/DC-8 PRO/DC-8 CV/DC-8EXP/DC-8SK132341	QBit SeriesTBD	Remark
DisplayAnnotations	Logo; Hospital Name;Examdate;Exam time; AcousticPower ;Mechanical index;Tissuethermal indes;ID,Last name,FirstName,Middleinitial, Gender, Age; Probemodel;ECG ico;Operator;TGCCorve;Focusposition;Thumbnail;Imagingparameters;Dynamic Trackballindices	Logo; Hospital Name;Examdate;Exam time; AcousticPower ;Mechanicalthermalindes;ID,Lastname,FirstName,Middleinitial, Gender, Age; Probemodel;ECG ico;Operator;TGCCorve;Focusposition;Thumbnail;Imagingparameters;Dynamic Trackballindices	Same
DisplayMonitor	19" high-resolution color LCDmonitor	15"/ 19" high-resolution colorLCD monitor	Same
Measurements	2D mode: Depth , DistanceArea: Ellipse, Trace, Spline,Cross,Trace Length , DoubleDistance , Parallel ,Volume:Distance, 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;	2D mode: Depth , DistanceArea: Ellipse, Trace, Spline,Trace Length , DoubleDistance , Parallel ,Volume:Distance, Ellipse, Ellipse +Distance, Distance Ratio,Area Ratio , IMT, VolumeFlow, Color Velocity;M mode: Distance,Time,Slope, Heart Rate,Velocity;Doppler mode: D Velocity ,Time,HeartRate,Acceleration ,DTrace,PS/ED , Volume Flow;	Same
TransducerTypes &Connectors	Convex Array, Phased Array,Linear Array, Volume probe4 ports	Convex Array, Phased Array,Linear Array, Volume probe4 ports	Same
UsersSites	Hospitals, clinics usage	Hospitals, clinics usage	Same
AcousticOutput	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm²maximum, TIS/TIB/TIC:0.1-4.0Range, Mechanical Index: 1.94.0Maximum, or Derated Isppa: 190W/cm² max	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm²maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index:1.9 Maximum, or DeratedIsppa: 190 W/cm² max	Same
	Predicate Device	Submission Device
ProductName(K number)	DC-8/DC-8 PRO/DC-8 CV/DC-8EXP/DC-8SK132341	QBit SeriesTBD	Remark
PowerRequirements	Power requirements:	Power requirements:	SE
	AC: 100-127V, or 220-240v	AC :100V- 240V,	Analysis
	Frequenzy: 50/60 Hz	Frequenzy:50-60Hz	2
	Operating temperature: 0-40° C; relative humidity 30-85%;Barometric pressure:700 to 1060 hPa	Operating temperature: 10-40° C; relative humidity 30-75%; Barometric pressure:700to 1060 hPa

Table 1 Substantial Equivalence Comparison

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{35}------------------------------------------------

{36}------------------------------------------------

Comparison Analysis

SE Analysis 1

The Operating Controls item of proposed device and the predicate device are with different Image Depth Range and Gain , but they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

SE Analysis 2

The Power Supply of the proposed device and the predicate device are AC :100V- 240V and 100-127V,or 220-240V , but both them comply with the requirements of IEC60601-1 and include the voltage range in the United States. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected. Therefore, power supply can be considered Substantially Equivalent in safety and effectiveness.

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 QBit Series - Diagnostic Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.

9. Substantially Equivalent Conclusion:

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.