Q Series Diagnostic Ultrasound System

• K Number: K153085
• Device Name: Q Series Diagnostic Ultrasound System
• Manufacturer: CHISON MEDICAL IMAGING CO., LTD.
• Date Cleared: 2015-12-21 ( 56 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K150861
• Predicate For: K162172 , K170374

Intended Use

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

Device Description

The Q 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 Tissue 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

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Q Series Diagnostic Ultrasound System

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

The provided text does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for a specific diagnostic task. Instead, it focuses on demonstrating substantial equivalence to a predicate device (QBit Series Diagnostic Ultrasound System, K150861) by comparing technical and functional specifications. The "acceptance criteria" here implicitly refer to the device safely and effectively performing within the established parameters and indications for use, similar to the predicate device.

Acceptance Criteria (Implicit from Substantial Equivalence Goal)	Reported Device Performance (Comparison to Predicate)
Indications for Use: The device performs within the specified clinical applications.	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 as predicate)
Design: Technical design and capabilities.	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 as predicate)
Operating Controls: User interface and control parameters.	TGC 8 slider, Depth Range: 0-30 cm, 256 shades of gray, B Dynamic range control: 30-180 dB, Gain: 0-255, 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 angle correction: -89~89 degrees, Baseline: 8 steps, Cine control: step, play backward, play continuously, Doppler Auto Trace, Freeze control: Toggling freeze key. (All Same as predicate)
Safety Compliance: Adherence to relevant safety standards.	IEC60601-1, IEC60601-1-2, IEC60601-2-37, ISO 10993-1. (Same as predicate)
Patient Contact Materials: Biocompatibility.	Bio-compatible. (Same as predicate)
Operation Mode: Available imaging modes.	B, THI, M, Color M, Free Steering M mode, Color Doppler Imaging, Power Doppler Imaging/Directional PD, Pulsed Wave Doppler, Continuous Wave Doppler, TDI, Contrast Imaging, 3D/4D, Elastography, Curved Panoramic, Trapezoidal image. (Same as predicate)
Display Modes: Combinations of imaging modes.	B, M, PW, CW, CFM, PD/DPD, TDI, 3D/4D; B+M, B+PW, B+CFM, B+PD/DPD, B+CFM+PW/CW, B+PW+PD/DPD. (Same as predicate)
Display Annotations: Information shown on the display.	Logo, Hospital Name, Exam date, Exam time, Acoustic Power, Mechanical index, Tissue thermal indices, ID, Last name, First Name, Middle initial, Gender, Age, Probe model, ECG ico, Operator, TGC Curve, Focus position, Thumbnail, Imaging parameters, Dynamic Trackball indices. (Same as predicate)
Display Monitor: Specifications of the display.	15" high-resolution color LCD monitor. (Same as predicate)
Measurements: Measurement capabilities.	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 as predicate)
Transducer Types & Connectors: Supported transducers.	Convex Array, Phased Array, Linear Array, Volume probe. (Predicate: 4 ports; Submission device: 2 ports. Deemed Substantially Equivalent in safety as both comply with IEC60601-1, and no new risk is raised.)
Users / Sites: Intended usage environments.	Hospitals, clinics usage. (Same as predicate)
Acoustic Output: Compliance with acoustic output limits.	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 as predicate)
Power Requirements: Electrical specifications.	AC: 100V-240V, Frequency: 50-60Hz, Operating temperature: 10-40°C, relative humidity 30-75%, Barometric pressure: 700 to 1060 hPa. (Same as predicate)

2. Sample size used for the test set and the data provenance:

The document explicitly states: "No clinical testing was required." This indicates that there was no test set of patient data used for clinical performance evaluation. The substantiation of equivalence was primarily through non-clinical testing and comparison of technical specifications to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical testing with a test set and ground truth established by experts was performed or required.

4. Adjudication method for the test set:

Not applicable, as no clinical testing with a test set was performed or required.

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

Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was mentioned.

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

Not applicable. This is a hardware diagnostic imaging system; it does not explicitly refer to an "algorithm only" performance separate from the system's overall function. The performance is inherent to the integrated ultrasound system.

7. The type of ground truth used:

Not applicable, as no clinical testing requiring ground truth was performed. The evaluation relied on compliance with engineering standards and direct comparison of specifications to a legally marketed predicate device.

8. The sample size for the training set:

Not applicable. As this approval is for a traditional diagnostic ultrasound system and not an AI/ML-driven device, there would not typically be a "training set" in the sense of machine learning. The system's design and performance are based on established ultrasound physics and engineering principles, and its functionality is validated against industry standards and predicate devices.

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

Not applicable, for the same reasons as #8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

December 21, 2015

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

Re: K153085

Trade/Device Name: O 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: October 21, 2015 Received: October 26, 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.

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

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

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

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

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

Sincerely yours,

Robert Oaks

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K153085

Device Name

Q Series Diagnostic Ultrasound System

Indications for Use (Describe)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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"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."

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Diagnostic Ultrasound Indications For Use

System: Q Series Diagnostic Ultrasound System

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N		N	N	N	3,5,6
	Abdominal	N	N	N		N	N	N	3,4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ(1) (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic	N	N	N	N	N	N	N	7
	Adult Cephalic	N	N	N	N	N	N	N	7
	Trans-rectal	N	N	N		N	N	N	4,5
	Trans-vaginal	N	N	N		N	N	N	3,4,5
	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	4,5,6
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	4,5,6

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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

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

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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	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

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

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Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
	Ophthalmic								5,6
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	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue 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	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	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue 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 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	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue 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
Fetal Imaging &Other	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	4,5,6
	Small Organ1 (Specify)	N	N	N	N	N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N	N	N	N	N	4,5,6
	Other (Urology)	N	N	N	N	N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	4,5,6

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

5. Includes guidance of biopsy(2D)

6.Tissue 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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	4,5,6
	Small Organ1 (Specify)	N	N	N	N	N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N	N	N	N	N	4,5,6
	Other (Urology)	N	N	N	N	N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	4,5,6

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

5. Includes guidance of biopsy(2D)

6.Tissue 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	N	4,5,6
	Small Organ1 (Specify)	N	N	N	N	N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N	N	N	N	N	4,5,6
	Other (Urology)	N	N	N	N	N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	4,5,6

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

5. Includes guidance of biopsy(2D)

6.Tissue 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)

{11}------------------------------------------------

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small 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)	N	N	N		N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	4,5,6

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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

{12}------------------------------------------------

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small 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)	N	N	N		N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	4,5,6

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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

{13}------------------------------------------------

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)	N	N	N		N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	4,5,6

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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

{14}------------------------------------------------

Clinical Application		Mode of Operation
General	Specific	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	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)	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)	N	N	N		N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	4,5,6

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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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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	N	N	N		N	N	N	4,5
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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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	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

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

Clinical Application		Mode of Operation							Other
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	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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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 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	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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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	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	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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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 Organ11 (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	N	N	4,5,6
	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	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

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

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	N	N	N	N	N	N	N	3,4,5,6
	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	4,5,6
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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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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	PW Doppler	CW Doppler	Color Doppler	Power Doppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N		N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small 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	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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

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

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	N	N	N	N	N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ11 (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	N	N	N	N	N	N	N	5,6
	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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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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	N	N	N		N	N	N	4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ11 (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	4,5,6
Cardiac	Cardiac Adult
	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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

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

Clinical Application		Mode of Operation							Other
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 Organ11 (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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

{26}------------------------------------------------

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 Organ11 (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:					F = added under this appendix			11

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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

{27}------------------------------------------------

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	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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small OrganII (Specify)
	Neonatal Cephalic				N
	Adult Cephalic				N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult				N
	Cardiac Pediatric				N
	Transesophageal
Peripheral Vessel	Peripheral vessel				N

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

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

5. Includes guidance of biopsy(2D)

6.Tissue 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	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

5. Includes guidance of biopsy(2D)

6.Tissue 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
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
	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

5. Includes guidance of biopsy(2D)

6.Tissue 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}------------------------------------------------

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
	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

5. Includes guidance of biopsy(2D)

6.Tissue Harmonic Imaging

7.TDI

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

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

{32}------------------------------------------------

510(k) Premarket Summary

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

1. Submitter:

Submitter:	Chison Medical Imaging Co., Ltd.
Address:	No.228, ChangJiang East Road, Block 51 and 53,Phase 5 Industrial Park, Shuo Fang, New District,Wuxi 214142, ChinaNo.9 Xin Hui Huan Road, New District, WuXi P.R. China
Contact:	Ms. Ruoli Mo
Tel:	[phone], 85310593
Fax:	[phone]
Date Prepared:	September 15, 2015

2. Device :

Trade Name: Q Series Diaqnostic Ultrasound System

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):

QBit Series Diagnostic Ultrasound System 510(k) Number: K150861

4. Device Description:

The Q 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 Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power

{33}------------------------------------------------

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 (Conventional , Superficial), Peripheral Vascular, Transesophageal, Transrectal, Transvaginal, Urology.

6. Summary of Non-Clinical Tests:

The Q 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 Safetv

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

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

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

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

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

7. Clinical Test:

No clinical testing was required.

8. Comparison to Predicate Device:

	Predicate Device	Submission Device
Product Name(K number)	QBit Series DiagnosticUltrasound SystemK150861	Q SeriesTBD	Remark
Indications forUse	FetalAbdominalPediatricSmall Organ (breast, thyroid, testes)Neonatal Cephalic, Adult	FetalAbdominalPediatricSmall Organ (breast, thyroid, testes)Neonatal Cephalic, Adult	Same
Product Name(K number)	Predicate DeviceQBit Series DiagnosticUltrasound SystemK150861	Submission DeviceQ SeriesTBD	Remark
	CephalicTrans-rectalTrans-vaginalMusculo-skeletal (Conventional,Superficial)Cardiac (adult, pediatric)Peripheral Vascular ;UrologyTransesophageal	CephalicTrans-rectalTrans-vaginalMusculo-skeletal (Conventional,Superficial)Cardiac (adult, pediatric)Peripheral VascularUrologyTransesophageal
Design	Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting Linear, Curve ,Phase array and Volume probes	Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting Linear, Curve ,Phase array and Volume probes	Same
	Cine play back capabilityImage file archive	Cine play back capabilityImage file archive
OperatingControls	TGC 8 slider	TGC 8 slider	Same
	Depth Range: 0 to 30 cm	Depth Range: 0 to 30 cm	Same
	256 shades of gray	256 shades of gray	Same
	B Dynamic range control: 30-180 dB, 5/step	B Dynamic range control: 30-180 dB, 5/step	Same
	Gain:0-255,1/step	Gain:0-255,1/step	Same
	Focal Number:1-4	Focal Number:1-4	Same
	Focus position: adjustable	Focus position: adjustable	Same
	B steer: available on lineartransducers	B steer: available on lineartransducers	Same
	B Persistence: 7 steps	B Persistence: 7 steps	Same
	ROI size/position: adjustable	ROI size/position: adjustable	Same
	Color Wall Filter settings:8 steps	Color Wall Filter settings:8 steps	Same
	Color Baseline: 16 steps	Color Baseline: 16 steps	Same
	Color Maps: 21 maps	Color Maps: 21 maps	Same
	Color Invert: on/off	Color Invert: on/off	Same
	PW sweeping speed: 6 steps	PW sweeping speed: 6 steps	Same
	PW Wall Filter: 7 steps	PW Wall Filter: 7 steps	Same
	PW sample volume: 0.5-30mm(PW only), 13 steps	PW sample volume: 0.5-30mm(PW only), 13 steps	Same
	PW angle correction:-89~89degrees, 1/step	PW angle correction:-89~89degrees, 1/step	Same
	Baseline: 8steps	Baseline: 8steps	Same
	Cine control: step, playbackward, play continuously	Cine control: step, playbackward, play continuously	Same
	Doppler Auto Trace	Doppler Auto Trace	Same
	Freeze control: Toggling freezekey	Freeze control: Toggling freezekey	Same
	Predicate Device	Submission Device
Product Name(K number)	QBit Series DiagnosticUltrasound SystemK150861	Q SeriesTBD	Remark
SafetyCompliance	IEC60601-1 Medical electricalequipment - Part 1: Generalrequirements for safetyIEC60601-1-2 Medical electricalequipment - Part 1-2: Generalrequirements for safety -Collateral standard:Electromagnetic compatibility -Requirements and testsIEC60601-2-37 Medicalelectrical equipment - Part 2-37:Particular requirements for thesafety of ultrasonic medicaldiagnostic and monitoringequipmentISO 10993-1 Biologicalevaluation of medical devices -Part 1: Evaluation and testingwithin a risk managementprocess	IEC60601-1 Medical electricalequipment - Part 1: Generalrequirements for safetyIEC60601-1-2 Medical electricalequipment - Part 1-2: Generalrequirements for safety -Collateral standard:Electromagnetic compatibility -Requirements and testsIEC60601-2-37 Medicalelectrical equipment - Part 2-37:Particular requirements for thesafety of ultrasonic medicaldiagnostic and monitoringequipmentISO 10993-1 Biologicalevaluation of medical devices -Part 1: Evaluation and testingwithin a risk managementprocess	Same
Patient ContactMaterials	Bio-compatible	Bio-compatible	Same
Operation Mode	B, FHI, M, Color M, FreeSteering M mode, Color DopplerImaging, Power DopplerImaging/Directional PD, PulsedWave Doppler, ContinuousWave Doppler, TDI, ContrastImaging, 3D/4D, Elastography,Curved Panoramic, Trapezoidalimage	B, FHI, M, Color M, FreeSteering M mode, Color DopplerImaging, Power DopplerImaging/Directional PD, PulsedWave Doppler, ContinuousWave Doppler, TDI, ContrastImaging, 3D/4D, Elastography,Curved Panoramic, Trapezoidalimage	Same
Display Modes	B, M, PW, CW, CFM, PD/DPD ,TDI, 3D/4D;B+M, B+PW, B+CFM,B+PD/DPD, B+CFM+PW/CW,B+PW+PD/DPD	B, M, PW, CW, CFM, PD/DPD ,TDI, 3D/4D;B+M, B+PW, B+CFM,B+PD/DPD, B+CFM+PW/CW,B+PW+PD/DPD	Same
	Predicate Device	Submission Device
Product Name(K number)	QBit Series DiagnosticUltrasound SystemK150861	Q SeriesTBD	Remark
DisplayAnnotations	Logo; Hospital Name; Examdate; Exam time; AcousticPower; Mechanical index; Tissuethermal indices; ID, Last name,First Name, Middle initial,Gender, Age; Probe model; ECGico; Operator; TGC Curve; Focusposition; Thumbnail; Imagingparameters; Dynamic Trackballindices	Logo; Hospital Name; Examdate; Exam time; AcousticPower; Mechanical index; Tissuethermal indices; ID, Last name,First Name, Middle initial,Gender, Age; Probe model; ECGico; Operator; TGC Curve; Focusposition; Thumbnail; Imagingparameters; Dynamic Trackballindices	Same
Display Monitor	15"high-resolution color LCDmonitor	15" high-resolution color LCDmonitor	Same
Measurements	2D mode: Depth , Distance,Area: Ellipse, Trace, Spline,Trace Length, Double DistanceParallel ,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 ,DTrace,PS/ED , Volume Flow;	2D mode: Depth , Distance,Area: Ellipse, Trace, Spline,Trace Length, Double DistanceParallel ,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 ,DTrace,PS/ED , Volume Flow;	Same
TransducerTypes &Connectors	Convex Array, Phased Array,Linear Array, Volume probe4 ports	Convex Array, Phased Array,Linear Array, Volume probe2ports	SEAnalysis
Users / Sites	Hospitals, clinics usage	Hospitals, clinics usage	Same
Acoustic Output	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm²maximum, TIS/TIB/TIC:0.1-4.0Range, Mechanical Index: 1.9Maximum, or Derated Isppa: 190W/cm² max	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm²maximum, TIS/TIB/TIC:0.1-4.0Range, Mechanical Index: 1.9Maximum, or Derated Isppa: 190W/cm² max	Same
PowerRequirements	Power requirements:AC :100V- 240V,Frequenzy:50-60HzOperating temperature: 10-40C; relative humidity 30-75%;Barometric pressure:700 to1060 hPa	Power requirements:AC :100V- 240V,Frequenzy:50-60HzOperating temperature: 10-40°C; relative humidity 30-75%;Barometric pressure:700 to1060 hPa	Same

Table 1 Substantial Equivalence Comparison

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

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

Comparison Analysis

{37}------------------------------------------------

SE Analvsis 1

The probe connectors of the proposed device and the predicate device are 2 ports and 4 ports, but both them comply with the requirements of IEC60601-1 . Therefore they can be considered Substantially Equivalent in safety , and no new risk is raised, so the SE is not affected. Therefore, probe connectors can be considered Substantially Equivalent in safety .

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

9. Substantially Equivalent Conclusion:

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

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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