(122 days)
No
The summary describes standard ultrasound imaging modes and processing techniques (autocorrelation, FFT) and does not mention any AI or ML capabilities. There is no mention of AI, DNN, or ML in the dedicated section, nor is there any description of training or test sets typically associated with AI/ML development.
No
The device is intended for diagnostic ultrasound imaging, not for therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging." Additionally, the "Device Description" reiterates that it is "intended for clinical diagnostic imaging applications" and is a "color diagnostic ultrasound system."
No
The device description explicitly states it consists of a mobile console with keyboard control panel, power supply module, color LCD monitor, and optional probes, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SonoAir Series Digital Color Doppler Ultrasound System is an ultrasound imaging system. It uses sound waves to create images of internal body structures. This is an in vivo diagnostic method (performed within the living body), not an in vitro method.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging" for various anatomical sites. This aligns with in vivo imaging, not testing of samples outside the body.
- Device Description: The description details the components and functions of an ultrasound machine, such as probes, console, and image processing techniques for ultrasound data.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the SonoAir Series Digital Color Doppler Ultrasound System is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic, Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The SonoAir Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (2D), Fusion Harmonic Imaging, M-Mode, Pulsed Doppler (PW) Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode or a combination of these mode.
Mentions image processing
Autocorrelation for color processing and FFT for pulse and CW Doppler processing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic, Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology.
Indicated Patient Age Range
Fetal, Pediatric, Adult
Intended User / Care Setting
appropriately-trained qualified clinician / hospital or medical clinic.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical testing was required.
Summary of Non-Clinical Tests: The SonoAir Series Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
March 31, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it, representing the Department of Health & Human Services-USA. To the right, there is a blue square with the letters 'FDA' in white, followed by the words 'U.S. FOOD & DRUG' in blue and 'ADMINISTRATION' in a smaller font size below.
CHISON Medical Technologies Co., Ltd. % Yingying Chen RA Specialist No.3 Changjiang South Road, Xinwu District Wuxi, Jiangsu 214028 CHINA
Re: K223570
Trade/Device Name: SonoAir Series Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: February 24, 2023 Received: February 27, 2023
Dear Yingying Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223570
Device Name
SonoAir Series Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic,
Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic.
Type of Use (Select one or both, as applicable) | |
---|---|
☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. Submitter:
Submitter: | CHISON Medical Technologies Co., Ltd. |
---|---|
Address: | No.3 Changjiang South Road, Xinwu District, Wuxi, 214028 Jiangsu, |
P.R. China | |
Contact : | Mrs. Chen Yingying |
Tel: | +86-510-8531-0019 |
Fax: | +86-510-8531-0021 |
Date Prepared: | October 14th, 2022 |
2. Device :
Trade Name: SonoAir Series Digital Color Doppler Ultrasound System
Common Name: Diagnostic Ultrasound System with Transducers
Classfication: 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 Ultrasound Transducer | 892.1570 | 90-ITX |
3. Predicate Device(s):
Device | Model | Product Code | 510(k)Number |
---|---|---|---|
Main predicate device | EBit 90 Digital Color | ||
Doppler Ultrasound System | IYN, IYO, ITX | K162172 | |
Reference device | XBit 90 Digital Color | ||
Doppler Ultrasound System | IYN, IYO, ITX | K200780 |
4. Device Description:
The SonoAir Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (2D), Fusion Harmonic Imaging, M-Mode, Pulsed
510(k) Summary
4
CHISON Medical Technologies Co., Ltd.
Doppler (PW) Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode or a combination of these mode.
5. Indications for Use:
The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD), B+DPD,B+PW, B+ CFM + D (PW), B+ CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by an appropriately-trained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ),Adult Cephalic,Cardiac Adult, Musculoskeletal(Conventional, Superficial),Peripheral Vascular, Trans-vaginal and Urology, which is intended to be used in a hospital or medical clinic.
6. Summary of Non-Clinical Tests:
The SonoAir Series Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.
ANSI AAMI ES60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
IEC 60601-2-37:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
Output Indices on Diagnostic Ultrasound Equipment
ISO 10993-1:2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process
The following quality assurance measures are applied to the development of the system:
Risk Management
Requirement review and Design reviews
Testing on unit level (Module verification)
Integration testing (system verification)
Performance testing (Verification)
Safety testing (Verification)
The biocompatibility was evaluated and meets the ISO10993 series standard and FDA guidance.
7. Clinical Test:
No clinical testing was required.
5
CHISON Medical Technologies Co., Ltd.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005", is also included as part of this submission.
8. Determination of Substantially Equivalent:
| Items | Main Predicate
Device | Reference Device | Submission Device | Remark |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Items | EBit 90 Digital Color
Doppler Ultrasound
System
(K162172) | XBit 90 Digital Color
Doppler Ultrasound
System
(K200780) | SonoAir Series
Digital Color Doppler
Ultrasound System | |
| Indicatio
ns for
Use | Fetal
Abdominal
Pediatric
Small Organ (breast,
thyroid ,testes)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-
skeletal( Conventiona
I, Superficial)
Cardiac(adult ,pediatr
ic)
Peripheral Vascular
Urology
Trans-esophageal | Fetal
Abdominal
Pediatric
Small Organ (breast,
thyroid ,testes)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-
skeletal( Conventiona
I, Superficial)
Cardiac(adult ,pediatr
ic)
Peripheral Vascular
OB/GYN,Urology
Trans-esophageal | Fetal
Abdominal
Pediatric
Small Organ (breast,
thyroid ,testes)
Adult Cephalic
Trans-vaginal
Musculo-
skeletal( Conventiona
I, Superficial)
Cardiac Adult
Peripheral Vascular
Urology | SE
Analysis
1 |
| Design | Autocorrelation for
color processing and
FFT for pulse and
CW Doppler
processing.
Supporting Linear,
Curve , Phase array
and Volume probes .
Cine play back
capability
Image file archive | Autocorrelation for
color processing and
FFT for pulse and
CW Doppler
processing.
Supporting Linear,
Curve , Phase array
and Volume probes .
Cine play back
capability
Image file archive | Autocorrelation for
color processing and
FFT for pulse and
CW Doppler
processing.
Supporting Linear,
Curve and Phase
array probes.
Cine play back
capability
Image file archive | Same |
| Operati | TGC 8 slider | TGC 8 slider | TGC 8 slider | Same |
| | Depth Range:0-30.8
cm | Depth Range: 0-45
cm | Depth Range:0- 22.7
cm | SE
Analysis
2 |
| ng
Controls | 256 shades of gray | 256 shades of gray | 256 shades of gray | Same |
| ltems | B Dynamic range
control: 30-180dB | B Dynamic range
control: 20-180dB | B Dynamic range
control: 30-180dB | Same |
| | Gain:0-255, 1/step | Gain:0-255, 1/step | Gain:0-255, 1/step | Same |
| | Focal Number:
adjustable | Focal Number:
adjustable | Focal Number:
adjustable | Same |
| | Focus position:
adjustable | Focus position:
adjustable | Focus position:
adjustable | Same |
| | B steer: available on
linear transducers | B steer: available on
linear transducers | B steer: available on
linear transducers | Same |
| | B Persistence: 7
steps | B Persistence: 7
steps | B Persistence: 7
steps | Same |
| | ROI size/position:
adjustable | ROI size/position:
adjustable | ROI size/position:
adjustable | Same |
| | Color Wall Filter
settings:8 steps | Color Wall Filter
settings:8 steps | Color Wall Filter
settings:4 steps | |
| | Color Baseline:16
steps | Color Baseline:16
steps | Color Baseline: 7
steps | SE
Analysis
2 |
| | Color Maps: 21 maps | Color Maps: 21 maps | Color Maps: 9 maps | |
| | PW sweeping speed:
6 steps | PW sweeping speed:
6 steps | PW sweeping speed:
3 steps | |
| | Color Invert: on/off | Color Invert: on/off | Color Invert: on/off | Same |
| | PW Wall Filter: 7
steps | 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) | PW sample volume:
1-8mm (PW only) | SE |
| | PW angle correction:-
8989degrees, 1/step | PW angle correction:-89degrees, 1/ste | PW angle correction:-
89
70-70degrees, 1/step | Analysis
2 |
| | Baseline: 8steps | Baseline: 8steps | Baseline: 6steps | |
| | Cine control:step,
play backward, play
continuously | Cine control:step,
play backward, play
continuously | Cine control:step,
play backward, play
continuously | Same |
| | Doppler Auto Trace | Doppler Auto Trace | Doppler Auto Trace | Same |
| | Freeze
control: Toggling
freeze key | Freeze
control: Toggling
freeze key | Freeze
control: Toggling
freeze key | Same |
| Safety
Compliance | ANSI AAMI
ES60601-1
IEC 60601-1-2
ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-23
IEC 60601-2-37 | ANSI AAMI
ES60601-1
IEC 60601-1-2
ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-23
IEC 60601-2-37 | ANSI AAMI
ES60601-1
IEC 60601-1-2
ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-23
IEC 60601-2-37 | Same |
| | | | | |
| Operation | B mode | B mode | B Mode | Same |
| | Dual mode | B/M Mode | B/B Mode | Same |
6
SonoAir Series Digital Color Doppler Ultrasound System
7
CHISON Medical Technologies Co., Ltd. | ||||||
---|---|---|---|---|---|---|
-- | -- | --------------------------------------- | -- | -- | -- | -- |
SonoAir Series Digital Color Doppler Ultrasound System
Mode | Quad mode | M mode | 4B Mode | Same |
---|---|---|---|---|
B/M Mode | Dual mode | B/M Mode | Same | |
M mode | Quad mode | M Mode | Same | |
CFM mode | CFM mode | CFM Mode | Same | |
PW mode | CPA Mode | PW Mode | Same | |
CPA(PD) Mode | DPD Mode | CPA(PD) Mode | Same | |
DPD Mode | PW mode | DPD Mode | Same | |
2D Steer | 2D Steer | 2D Steer | Same | |
Triplex Mode | Triplex Mode | Triplex Mode | Same | |
Quadplex Mode | Quadplex Mode | Quadplex Mode | Same | |
/ | HD 3D Mode | HD 3D Mode | Same | |
Free Steer M | Free Steering M | Free Steer M | Same | |
HPRF Mode | HPRF Mode | HPRF Mode | Same | |
FHI | FHI | FHI | Same | |
Color M Mode | Color M Mode | Color M Mode | Same | |
Trapezoidal Mode | Trapezoidal Mode | Trapezoidal Mode | Same | |
Elastography Mode | Elastography Mode | Elastography Mode | Same | |
/ | Sono Contrast | Sono Contrast | Same | |
Super Needle | Super Needle | Super Needle | Same | |
Biopsy | / | Biopsy | Same | |
Curved Panoramic | Curved Panoramic | Curved Panoramic | Same | |
TGC | / | TGC | Same | |
/ | LGC | LGC | Same | |
Chroma | Chroma | Chroma | Same | |
/ | X-contrast | X-contrast | Same | |
Q-beam | Q-beam | Q-beam | Same | |
Compound | Compound | Compound | Same | |
AIO | AIO | AIO | Same | |
SRA | SRA | SRA | Same | |
Q-image | Q-image | Q-image | Same | |
general measurement | ||||
package | general measurement | |||
package | general measurement | |||
package | Same | |||
OB measurement | ||||
package | OB measurement | |||
package | OB measurement | |||
package | Same | |||
GYN measurement | ||||
package | GYN measurement | |||
package | GYN measurement | |||
package | Same | |||
URO measurement | ||||
package | URO measurement | |||
package | URO measurement | |||
package | Same | |||
cardiac measurement | ||||
package | cardiac measurement | |||
package | cardiac measurement | |||
package | Same |
8
CHISON Medical Technologies Co., Ltd. | SonoAir Series Digital Color Doppler Ultrasound System | ||||||
---|---|---|---|---|---|---|---|
vascular | |||||||
measurement | |||||||
package | vascular | ||||||
measurement | |||||||
package | Same | ||||||
small parts | |||||||
measurement | |||||||
package | small parts | ||||||
measurement | |||||||
package | Same | ||||||
Pediatric | |||||||
measurement | |||||||
package | Pediatric | ||||||
measurement | |||||||
package | Same | ||||||
TCD measurement | |||||||
package | TCD measurement | ||||||
package | Same | ||||||
/ | Free OB | Same | |||||
Bodymark | Bodymark | Same | |||||
Auto IMT | Auto IMT | Same | |||||
/ | SonoColor | Same | |||||
Stress Echo | Stress Echo | Same | |||||
/ | Strain and Strain | ||||||
Rate | Same | ||||||
Display | |||||||
Annotations | Logo; Hospital Name; | ||||||
Exam date;Exam | |||||||
time; AcousticPower; | |||||||
Mechanical index; | |||||||
Tissue thermal indes; | |||||||
ID,Last name,First | |||||||
Name,Middleinitial, | |||||||
Gender, Age; | |||||||
Probe model;ECG | |||||||
ico;Operator; | |||||||
TGC Corve;Focus | |||||||
position;Thumbnail; | |||||||
Imagingparameters; | |||||||
Dynamic | Logo; Hospital Name; | ||||||
Exam date;Exam | |||||||
time; Acoustic | |||||||
Power ; | |||||||
Mechanical | |||||||
index;Thermal | |||||||
indes;Probe | |||||||
model;ECG ico;TGC | |||||||
Corve;Focus | |||||||
position;Imaging | |||||||
parameters;Dynamic | |||||||
Trackball indices; | |||||||
System | |||||||
status;Gray/Color bar | Logo; Hospital Name; | ||||||
Exam date;Exam | |||||||
time; Acoustic | |||||||
Power ; | |||||||
Mechanical | |||||||
index;Thermal | |||||||
indes;Probe model; | |||||||
TGC Corve;Focus | |||||||
position;Imaging | |||||||
parameters;TTouch | |||||||
pad; System | |||||||
status;Gray/Color bar | Same |
9
SonoAir Series Digital Color Doppler Ultrasound System
| Measurements | 2D mode: Depth ,
Distance ,Area:
Ellipse, Trace, Spline,
Cross, Trace Length,
Double Distance,
Parallel, Volume:
Distance, Ellipse,
Ellipse + Distance,
Length Ratio, Area
Ratio, IMT, B
Histogram, B Profile,
Volume Flow, Color
Velocity;
M mode: Distance,
Time, Slope, Heart
Rate, Velocity;
Doppler mode: D
Velocity, Time, Heart
Rate, Acceleration, D
Trace, PS/ED,
Volume Flow; | 2D mode: Depth ,
Distance ,Area:
Ellipse, Trace, Spline,
Trace Length ,
Double Distance
Parallel ,Volume :Dist
ance, 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; | 2D mode: Depth ,
Distance ,Area:
Ellipse, Trace, Spline,
Trace,
Length ,Volume : Dist
ance, Ellipse, Ellipse - Distance, Distance
Ratio, Area Ratio ,
IMT, Volume Flow;
M mode:
Distance,Time,
Slope,Heart
Rate,Velocity;
Doppler mode: D
Velocity ,Time ,
Heart Rate,
Acceleration ,D
Trace,ED/PS,
Volume Flow; | Same |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Transducer
Types &
Connect
ors | Convex Array,
Phased Array, Linear
Array, Volume probe
2 ports | Convex Array,
Phased Array, Linear
Array,Volume probe
4ports | Convex Array,
Phased Array, Linear
Array,
4ports | Same |
| Users /
Sites | Hospitals, clinics
usage | Hospitals, clinics
usage | Hospitals, clinics
usage | Same |
| Acoustic
Output | Track 3; MI, TIS,
TIC, TIB
Derated Ispta:
720mW/cm²
maximum,
TIS/TIB/TIC:0.1-4.0
Range, Mechanical
Index: 1.9 Maximum,
or Derated Isppa: 190
W/cm² max | Track 3; MI, TIS,
TIC, TIB
Derated Ispta:
720mW/cm²
maximum,
TIS/TIB/TIC:0.1-4.0
Range, Mechanical
Index: 1.9 Maximum,
or Derated Isppa: 190
W/cm² max | Track 3; MI, TIS,
TIC, TIB
Derated Ispta:
720mW/cm²
maximum,TIS/TIB/TI
C:0.1-4.0 Range,
Mechanical Index: 1.9
Maximum, or Derated
Isppa: 190 W/cm²
max | Same |
| Power
Requirements | Power requirements:
AC :100V- 240V,
Frequenzy:50-60Hz
Operating
temperature: 10-40°
C; relative humidity
30-75%;
Barometric pressure:
700 to 1060hPa | Power requirements:
AC :100V- 240V,
Frequenzy:50-60Hz
Operating
temperature:
0-40°C; relative
humidity 30-75%;
Barometric pressure:
700 to 1060 hPa | Power requirements:
AC :100V- 240V,
Frequenzy:50-60Hz
Operating
temperature:
10-38°C; relative
humidity 30-75%;
Barometric pressure:
700 to 1060 hPa | SE
Analysis
3 |
SE Analysis 1:
Compared with the predicate device, the submission device has some differences in
10
CHISON Medical Technologies Co., Ltd.
indications for use. Principles of operation transducer configuration is the same, the only difference is the number of probe. Both of the predicate and submission device comply with the requirements of ANSI AAMI ES60601-1& IEC 60601-2-37 and meet clinical requirements. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
SE Analysis 2:
Operation Controls, compared with the predicate device, the submission device employs the same operation controls design ,but has some differences in setting range. But both of them comply with the requirements of ANSI AAMI ES60601-1 & IEC60601-2-37 and meet clinical requirements. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
SE Analysis 3:
Compared with the predicate device, the submission device has some differences in operating temperature. But the operating temperature of the device is contained within the scope of the predicate device. Both them comply with the requirements of ANSI AAMI ES60601-1. Therefore they can be considered Substantially Equivalent in safety, and no new risk is raised, so the SE is not affected.
9. Conclusion
In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, CHISON Medical Technologies Co., Ltd. concludes that the SonoAir Series Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.