(264 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically involve AI or ML, such as automated image analysis, diagnosis assistance, or predictive modeling. The description focuses on standard ultrasound imaging modes and data transmission.
No
Explanation: The device is described as a "diagnostic ultrasound system" intended for "diagnostic ultrasound echo imaging, measurement, and fluid flow analysis." Its purpose is to acquire and display ultrasound data for diagnosis, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data... The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body..."
No
The device description explicitly states that the system consists of a "EdgeLife Handheld Ultrasound Scanner" which is a hardware component (Model E8200 and E8220 with transducers). While it is software-controlled and uses an app, it is not solely software.
Based on the provided information, the EdgeLife Handheld Wireless Ultrasound System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- EdgeLife System Function: The EdgeLife system uses ultrasound technology to image the inside of the human body directly. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it is for "diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body." This is in vivo (within the living body) imaging, not in vitro.
Therefore, the EdgeLife Handheld Wireless Ultrasound System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable softwarecontrolled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.
The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.
The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).
The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.
The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
Product codes
IYN, IYO, ITX
Device Description
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes.
The EdgeLife Ultrasound Scanner receives instructions from and transmits images to the EdgeLife Ultrasound App running on a paired mobile device that utilizes the iOS operating system via wireless Wi-Fi communication.
The system is a transportable ultrasound system intended for use in environments where healthcare is provided.
The EdgeLife Handheld Wireless Ultrasound System consists of:
- EdgeLife Handheld Ultrasound Scanner:
- o Model E8200 with convex and linear transducers
- o Model E8220 with convex and endocavitary transducers
- EdgeLife Ultrasound App .
- Standard off-the-shelf Wireless Qi charger (not a medical device)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body, pulmonary, obstetrics, and cardiac. Specific transducer for transvaginal and transrectal.
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
Trained healthcare professionals in hospitals, clinics, and other professional healthcare facility settings.
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)
Non-Clinical Performance Testing: Biocompatibility, Thermal, Electrical, and Mechanical Safety, Cleaning and Disinfection, Non-Clinical Verification Testing, Software Verification and Validation. All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
September 18, 2024
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EdgeLife Technologies LLC % Quinn Place Chief Operating Officer 485 Brickell Avenue Suite 4802 Miami, Florida 33031
Re: K234153
Trade/Device Name: EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 13, 2023 Received: August 23, 2024
Dear Quinn Place:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about medical devices and radiation-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
3
Indications for Use
510(k) Number (if known) K234153
Device Name
EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
Indications for Use (Describe)
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable softwarecontrolled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.
The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.
The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).
The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.
The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE . TECHNOLOGIES", with the word "LIFE" in blue, a red dot in the middle, and the word "TECHNOLOGIES" in blue.
K234153
EdgeLife Handheld Wireless Ultrasound System - 510(k) Summary
The following 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
| Subject Device Trade Name: | EdgeLife Handheld Wireless Ultrasound System |
|---|---|
| Subject Device Model Numbers: | E8200, E8220 |
| Common Name: | Diagnostic Ultrasound System and Accessories |
| Regulation Number | Regulation Name | Product Code |
|---|---|---|
| 21 CFR § 892.1550 | Ultrasonic Pulsed Doppler Imaging | |
| System | IYN | |
| 21 CFR § 892.1560 | Ultrasonic Pulsed Doppler Imaging | |
| System | IYO | |
| 21 CFR § 892.1570 | Diagnostic Ultrasonic Transducer | ITX |
Regulation Number, Name and Product Codes 1.1
| FDA 510(k) Review Panel: | Radiology |
|---|---|
| Classification: | Class II |
| Manufacturer: | Edge Life Technologies |
| 485 Brickell Avenue, Suite 4802 | |
| Miami, Florida 33031 U.S.A. | |
| Contact Name: | Quinn Place, Chief Operating Officer |
| qplace@edgelifetech.com | |
| Date 510(k) Summary Prepared: | December 20, 2023 |
| Predicate Device: | Vscan Air K202035 |
| Reference Device: | Clarius Ultrasound Scanner K192107 |
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Image /page/5/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE • TECHNOLOGIES", with the word "LIFE" in black, a red dot in the middle, and the word "TECHNOLOGIES" in black. The logo is simple and modern.
1.2 Device Description
The EdgeLife Handheld Wireless Ultrasound System, including Scanners, follows Track 3.
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes.
The EdgeLife Ultrasound Scanner receives instructions from and transmits images to the EdgeLife Ultrasound App running on a paired mobile device that utilizes the iOS operating system via wireless Wi-Fi communication.
The system is a transportable ultrasound system intended for use in environments where healthcare is provided.
The EdgeLife Handheld Wireless Ultrasound System consists of:
- EdgeLife Handheld Ultrasound Scanner:
- o Model E8200 with convex and linear transducers
- o Model E8220 with convex and endocavitary transducers
- EdgeLife Ultrasound App .
- Standard off-the-shelf Wireless Qi charger (not a medical device) ●
Indications for Use 1.2.1
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.
The specific clinical applications and exam types for the linear transducer include vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system,
6
Image /page/6/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE • TECHNOLOGIES" in smaller, gray letters. The bullet point between the words "LIFE" and "TECHNOLOGIES" is red.
non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.
The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, gynecology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).
The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.
The system is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
1.2.2 Comparison of Subject Device and Predicate Device
Comparison of intended use and technological characteristics between EdgeLife Handheld Wireless Ultrasound Scanner and the predicate device, Vscan Air, is presented in the following table.
| | EdgeLife Handheld
Wireless Ultrasound
System | Vscan Air
(K202035) | Substantial Equivalence
Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scanner Type | Dual-Headed | Dual-Headed | Same |
| Transducer | Convex and Linear
(E8200)
Convex and Endocavitary
(E8220) | Convex and
Linear | Similar |
| | | | The subject and predicate
have the same convex and
linear transducers. The
subject device also
includes an endocavitary
transducer on one of the
dual headed probes.
Endocavitary transducers
are commonly found in
current ultrasound systems
including the predicate
device. Performance test
results support that this |
| | EdgeLife Handheld
Wireless Ultrasound
System | Vscan Air
(K202035) | Substantial Equivalence
Comparison |
| | | | difference does not raise
new questions of safety
and effectiveness. |
| Classification | Class II | Class II | Same |
| Product Codes | IYN, IYO, ITX | ITX, IYN,
IYO | Same |
| Clinical Settings | Hospitals, clinics and other
professional healthcare
facility settings | Hospitals,
clinics and
medical office
settings, home,
emergency
environments | Similar. The only
difference is that the
subject device is not
intended for use in home
health or road/air
ambulance environments.
This difference does not
raise new questions of
safety and effectiveness. |
| Users | Trained Healthcare
professionals | Trained
Healthcare
professionals | Same |
| Patient
Population | adult and pediatric | adult and
pediatric | Same |
| Intended Use | Diagnostic ultrasound
imaging and fluid flow
analysis. | Diagnostic
ultrasound
imaging and
fluid flow
analysis | Same |
| Indications for
Use | The EdgeLife Handheld
Wireless Ultrasound
System is a
general-purpose, handheld,
wireless, portable
software-controlled
ultrasonic diagnostic
system that uses
pulsed-echo technology to
acquire and display
ultrasound data in B-Mode,
M-Mode, Color Doppler,
and Pulse-Wave Doppler
(PW) modes. The
EdgeLife Handheld
Wireless Ultrasound
System is intended for | Refer to
K202035
510(k)
Summary. | Similar. Both subject and
predicate devices are
intended for diagnostic
ultrasound echo imaging,
measurement and analysis
of the human body for the
same applications.
The subject device also
includes an endocavitary
transducer that allows for
clinical applications
including gynecology,
obstetrics, urology,
transvaginal, transrectal,
and interventional
procedures. These |
| EdgeLife Handheld
Wireless Ultrasound
System | Vscan Air
(K202035) | Substantial Equivalence
Comparison | |
| imaging, measurement,
and fluid flow analysis of
the human body for the
following clinical
applications.
The specific clinical
applications and exam
types for the linear
transducer include
vascular/peripheral
vascular, musculoskeletal
(conventional and
superficial), small organs,
thoracic/lung, abdominal,
intraoperative (excluding
neurological, central
nervous system,
non-central cardiovascular
system), urology,
gynecology, pediatric,
fetal, peripheral vessel,
carotid, interventional and
procedure guidance of
needles into the body.
The specific clinical
applications and exam
types for the convex
transducer include:
abdominal, pulmonary,
thoracic, intra-operative
(abdominal organs &
vascular), pediatric, small
organ, urology,
gynecology, obstetrics,
musculoskeletal
(conventional and
superficial), vascular,
carotid, and cardiac (adult
and pediatric). | | application types are
found in other legally
marketed ultrasound
systems including the
Reference Device and are
not novel. Performance
data support the
indications for use.
Therefore, these
differences do not raise
new questions of safety
and effectiveness. | |
| | EdgeLife Handheld
Wireless Ultrasound
System | Vscan Air
(K202035) | Substantial Equivalence
Comparison |
| | The specific clinical
applications and exam
types for the Endocavitary
transducer include
gynecology, obstetrics,
urology, transvaginal,
transrectal, and
interventional procedures.
The system is a portable
ultrasound system intended
for use in environments
where healthcare is
provided by trained
healthcare professionals. | | |
| Portability | Handheld portable | Handheld
portable | Same |
| System
Components | Dual-headed probes
Mobile app
Charger | Dual-headed
probe
Mobile app
Charger | Same. |
| Frequency | Convex:2-5 MHz with
center frequency of 3.2
MHz
Linear 4-12 MHz, with
center frequency of 7.5
MHz
Endocavitary: 4-9 MHz
with the center frequency
of 6.5 MHz | Convex: from
2 - 5 MHz with
center
frequency of
3.3 MHz
Linear: From 3
- 12 MHz with
center
frequency of
7.7 MHz | Similar. The differences
don't raise any issues
about safety and
effectiveness of the
device. |
| Elements | All transducers have 128
elements | GE: Linear
192, convex:
192 | Similar. The differences
don't raise any issues
about safety and
effectiveness of the
device. |
| Display | iOS device | iOS or Android
device | Similar. This difference
does not raise new
questions of safety or
effectiveness. |
| | EdgeLife Handheld
Wireless Ultrasound
System | Vscan Air
(K202035) | Substantial Equivalence
Comparison |
| Software | Mobile app downloads on
iOS viewing device | Mobile app
downloads on
iOS and
Android
viewing device | Similar. This difference
does not raise new
questions of safety or
effectiveness. |
| Image Format | JPG and DICOM, DICOM
transfer to PACS or
imaging archive systems | JPG and
DICOM,
DICOM
transfer to
PACS or
imaging
archive
systems | Same |
| Penetration depth | Convex up to 30 cm
Linear Biocompatibility | | |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Irritation | ISO 10993-23 Skin Irritation | Non-irritating |
| | ISO 10993-23 Vaginal Irritation | Non-irritating |
| Sensitization | ISO 10993-10 | Non-sensitizing |
| Thermal, Electrical, and Mechanical Safety | | |
| Electrical Safety | ANSI AAMI ES 60601-1 | Pass |
| Battery Safety | IEC 62133-2
UN38.3 | Pass |
| Electromagnetic
Compatibility | IEC 60601-1-2 | Pass |
| Wireless
Coexistence | ANSI C63.27
AAMI TIR69 | Pass |
| FCC Certification | FCC 15, FCC 18 | Certified |
| Acoustic Output | IEC 60601-2-37
IEC 62359 | Pass, Track 3 |
| Cleaning and Disinfection | | |
| Model E8200 | AAMI TIR30, AAMI TIR12 | Pass |
| Model E8220 | AAMI TIR30, AAMI TIR12 | Pass |
| Non-Clinical Verification Testing | | |
| Measurement
Accuracy | Internal test methods | Pass |
| Software Verification and Validation | | |
| Software verification and validation | | Pass |
| Table 4: Summary of Non-Clinical Performance Testing | ||
|---|---|---|
| -- | ------------------------------------------------------ | -- |