Vscan Air (K202035)
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging capabilities and software processing.
No.
The device is described as a diagnostic ultrasound imaging system for visualization and measurement of anatomical structures and fluid, specifically for clinical diagnosis purposes and interventional guidance. It does not provide any therapeutic function.
Yes
The "Device Description" section explicitly states, "Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system." Additionally, the "Intended Use / Indications for Use" section mentions, "The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes."
No
The device description explicitly states that Vscan Air consists of an app and 2 probes, which are hardware components.
Based on the provided information, the Vscan Air is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Vscan Air is an ultrasound imaging system that directly visualizes and measures anatomical structures and fluid within the body using ultrasonic waves. It does not analyze blood, urine, tissue samples, or any other bodily fluids or tissues in vitro (outside the body).
- The intended use and device description clearly state its function as an imaging system. The focus is on visualization, measurement, and guidance for clinical diagnosis and procedures, not on analyzing biological samples.
Therefore, the Vscan Air falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage.
Vscan Air supports black/white (B-mode), color flow (Color Doppler mode, M-mode, M-mode, combined (B + Color Doppler) and Harmonic Imaging modes with curved, linear and sector array transducers.
With the curved array transducer of the dual headed probesolution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatio, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung, ophthalmic, pediatics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
With the sector array transducer of the dual headed probe solution, the specific clinical applications and exam types include: cardiac (adult and pediatic, 40 kg and above), abdominal, fetal/obstetnes, gynecological, urology, thoracic/ lung, pediatics, adult cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
Product codes
IYN, IYO, ITX
Device Description
Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid.
Vscan Air consists of an app which can be installed on Android™ or iOS devices, and 2 probes which use wireless technology for communication.
Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.
Mentions image processing
The proposed Vscan Air uses a software app which can be installed on user's mobile device that provides some of the processing and uses the screen of the mobile device as the display, same as the predicate device Vscan Air (K202035).
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac, vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, ophthalmic, neonatal cephalic, adult cephalic.
Indicated Patient Age Range
adult, pediatric, neonatal
Intended User / Care Setting
Qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.
Professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as described in the user manual.
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)
Summary of Clinical Tests: The subject of this premarket submission, Vscan Air, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vscan Air (K202035)
Reference Device(s)
Vscan Extend (K180995), Venue Go (K220800)
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
August 15, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
GE Medical Systems Ultrasound and Primary Care Diagnostics % Lee Bush Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K231301
Trade/Device Name: Vscan Air Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 1, 2023 Received: August 1, 2023
Dear Lee Bush:
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
Image /page/2/Picture/0 description: The image shows the text "GE Healthcare" at the top, followed by the text "510(k) Premarket Notification Submission" on the next line. The text is in a simple, sans-serif font and is centered on the image. The text is likely part of a document or presentation related to GE Healthcare's regulatory submissions.
Image /page/2/Picture/6 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are swirling water-like designs around the edge of the circle. The logo is simple and recognizable.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | See PRA Statement below. |
| | |
| 510(k) Number (if known) | |
| K231301 | |
| Device Name | |
| Vscan Air | |
| | |
| Indications for Use (Describe) | |
| Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and
trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other
local municipality in which he or she practices. The users may or may not be working under supervision or authority of a
physician. Users may also include medical students working under the supervision or authority of a physician during their
education / training. The device is enabling visualization and measurement of anatomical structures and fluid including
blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and
examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air
ambulance and other environments as described in the user manual. The information can be used for basic/focused
assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up,
and triage.
Vscan Air supports black/white (B-mode), color flow (Color Doppler mode, M-mode, M-mode, combined
(B + Color Doppler) and Harmonic Imaging modes with curved, linear and sector array transducers.
With the curved array transducer of the dual headed probesolution, the specific clinical applications and exam types
include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatio, 40 kg and above),
vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand
needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types
include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung,
ophthalmic, pediatics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid
drainage, nerve block, vascular access and biopsy).
With the sector array transducer of the dual headed probe solution, the specific clinical applications and exam types
include: cardiac (adult and pediatic, 40 kg and above), abdominal, fetal/obstetnes, gynecological, urology, thoracic/ | |
| lung, pediatics, adult cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, | |
| nerve block and biopsy). | |
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov
"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." | |
| Dago 1 of 1 | |
FORM FDA 3881 (6/20)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 4, 2023 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Lee Bush |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)309-9429 | |
| Secondary Contact Person: | Liwen Wei |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Trade Name: | Vscan Air |
| Common/Usual Name: | Diagnostic Ultrasound Imaging System |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN; |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Predicate Device: | Vscan Air (K202035) |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN; |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
4
Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. There are also three water droplets or stylized swirls surrounding the circle, adding a dynamic element to the design. The logo is simple, recognizable, and represents the brand identity of General Electric.
| Reference Devices: | Vscan Extend (K180995) |
|---|---|
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN; |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
Venue Go (K220800)
Ultrasonic Pulsed Doppler Imaging System. 21CFR, 892.1550 90-IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Device Description: | Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound
imaging system for use by qualified and trained healthcare professionals.
It enables ultrasound imaging guidance, visualization and measurement
of anatomical structures and fluid.
Vscan Air consists of an app which can be installed on Android™ or iOS
devices, and 2 probes which use wireless technology for communication.
Its pocket-sized portability and simplified user interface enable
integration into training sessions and examinations in professional
healthcare facilities (ex. Hospital, clinic, medical office), home
environment, road/air ambulance and in other environments. The
information can be used for basic/focused assessments and adjunctively
with other medical data for clinical diagnosis purposes during routine,
periodic follow-up, and triage assessments for adult, pediatric and
neonatal patients. Vscan Air can also be useful for interventional
guidance. |
| | |
| Intended Use/ Indications
for Use: | Vscan Air is a battery-operated software-based general-purpose
ultrasound imaging system for use by qualified and trained healthcare
professionals or practitioners that are legally authorized or licensed by law
in the country, state or other local municipality in which he or she
practices. The users may or may not be working under supervision or
authority of a physician. Users may also include medical students working
under the supervision or authority of a physician during their education /
training. The device is enabling visualization and measurement of
anatomical structures and fluid including blood flow. |
| | Vscan Air's pocket-sized portability and simplified user interface enables
integration into training sessions and examinations in professional
healthcare facilities (ex. Hospital, clinic, medical office), home
environment, road/air ambulance and other environments as described
in the user manual. The information can be used for basic/focused
assessments and adjunctively with other medical data for clinical
diagnosis purposes during routine, periodic follow-up, and triage. |
| | Vscan Air supports Black/ white (B-mode), Color flow (Color doppler),
Pulsed wave Doppler mode, M-mode, combined (B + Color Doppler) and
Harmonic Imaging modes with curved, linear and sector array
transducers.
With the curved array transducer of the dual headed probe solution, the
specific clinical applications and exam types include: abdominal,
fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and
pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal
(conventional), pediatrics, interventional guidance (includes free hand
needle/catheter placement, fluid drainage, nerve block and biopsy). |
| | With the linear array transducer of the dual headed probe solution, the
specific clinical applications and exam types include: vascular/peripheral
vascular, musculoskeletal (conventional and superficial), small organs,
thoracic/lung, ophthalmic, pediatrics, neonatal cephalic, interventional
guidance (includes free hand needle/catheter placement, fluid drainage,
nerve block, vascular access and biopsy). |
| | With the sector array transducer of the dual headed probe solution, the
specific clinical applications and exam types include: cardiac (adult and
pediatric, 40 kg and above), abdominal, fetal/obstetrics, gynecological,
urology, thoracic/ lung, pediatrics, adult cephalic, interventional guidance
(includes free hand needle/catheter placement, fluid drainage, nerve
block and biopsy). |
| Technology: | The Vscan Air employs the same fundamental scientific technology as its
predicate and reference devices. |
| Determination of
Substantial Equivalence: | Comparison to Predicate Devices
The Vscan Air system is substantially equivalent to the predicate and
reference devices with regards to intended use, capabilities, technological
characteristics, safety and effectiveness. |
| | Intended Use/Indications for Use |
| | The systems are intended for diagnostic ultrasound imaging and fluid flow
analysis
The proposed Vscan Air and the predicate Vscan Air (K202035) have the
similar clinical intended use and clinical applications however the
following applications are being added to the proposed Vscan Air:
• Adult Cephalic, which can be found in reference device Vscan
Extend (K180995). |
| | Modes and Transducers |
| | The proposed Vscan Air and the predicate Vscan Air (K202035) both
support Black/white (B-mode), Color flow (Color doppler), combined (B +
Color Doppler) and Harmonic Imaging modes. In addition, the proposed
Vscan Air also supports Pulsed wave Doppler mode and M-mode, which
are cleared in reference device Venue Go (K220800). |
| | The proposed Vscan Air probes and the predicate Vscan Air (K202035)
probe are manufactured with materials which have been evaluated and
found to be safe for the intended use of the device. The proposed Vscan
Air and the predicate Vscan Air (K202035) use the same linear array
transducer for shallow scanning and curved array transducer for deep
scanning. In addition, by introducing the new Vscan Air SL probe, the
proposed Vscan Air adds a sector array for deep scanning, which is similar
to the sector array that is cleared in reference device Vscan Extend
(K180995). |
| | Software |
| | The proposed Vscan Air uses a software app which can be installed on
user's mobile device that provides some of the processing and uses the
screen of the mobile device as the display, same as the predicate device
Vscan Air (K202035). |
| | The proposed Vscan Air has additional TCD (Transcranial Doppler) preset
for Adult Cephalic application which is cleared in reference device Vscan
Extend (K180995). The proposed Vscan Air supports same distance and |
5
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6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are decorative, swirling lines around the outer edge of the circle, giving the impression of movement or energy. The logo is simple, recognizable, and associated with a large, multinational corporation.
7
Image /page/7/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle is surrounded by a series of white, teardrop-shaped elements, resembling water droplets or stylized flames. The overall design is clean and recognizable, representing the brand identity of General Electric.
time and angle measurements and OB measurement display, which are cleared in reference device Venue Go (K220800) The proposed Vscan Air adds an annotation function to software app to add/delete/modify free text as labels on image, which is used in reference device Venue Go (K220800). The proposed Vscan Air and the predicate Vscan Air (K202035) both have a transducer element check function, however, the proposed Vscan Air made improvements to quickly assess health of transducers as soon as the probe starts up. The proposed Vscan Air software app allows probes to be on low-powerconnected mode while probe is in freeze mode or charging, for power saving and convenience of continuous scanning after probe charging. The proposed Vscan Air adds more basic patient information fields, configuration settings, and basic calculations, which are used in reference device Venue Go (K220800). Hardware The proposed Vscan Air uses Wi-Fi technology (Wi-Fi direct) to communicate between the probe and the mobile device with the installed Vscan Air app, same as predicate device Vscan Air (K202035). The proposed Vscan Air uses wireless charging technology to charge the Vscan Air CL and Vscan Air SL Probe batteries, same as predicate device Vscan Air (K202035). The proposed Vscan Air and predicate Vscan Air (K202035) have been designed in compliance with approved electrical and physical safety standards. Summary of Non-Clinical Tests The Vscan Air device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection as well as thermal, electrical, electromagnetic, mechanical safety and wireless, and has been found to conform to applicable medical device safety standards. The Vscan Air and its applications comply with voluntary standards: ● AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance, 2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text)
ellipse measurement as predicate Vscan Air (K202035) and adds velocity,
8
Image /page/8/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a darker blue background.
| IEC 60601-1-2, Medical Electrical Equipment – Part 1-2: General
Requirements for Safety and Essential Performance - Collateral
Standard: Electromagnetic disturbance - Requirements and Tests,
Edition 4.1, 2020 IEC 60601-2-37, Medical Electrical Equipment – Part 2-37:
Particular Requirements for the Safety of Ultrasonic Medical
Diagnostic and Monitoring Equipment, 2015 ISO 10993-1, Biological Evaluation of Medical Devices- Part 1:
Evaluation and Testing- Fifth edition 2018-08 ISO 14971, Application of risk management to medical devices,
2019 Edition 2.1 IEC 62359, Ultrasonics – Field characterization – Test methods for
the determination of thermal and mechanical indices related to
medical diagnostic ultrasonic fields, Edition 2.1, 2017 IEC 60601-1-11, Medical Electrical Equipment - Part 1-11: General
Requirements For Basic Safety And Essential Performance -
Collateral Standard: Requirements For Medical Electrical
Equipment And Medical Electrical Systems Used In The Home
Healthcare Environment, Edition 2.1 2020-07 CONSOLIDATED
VERSION IEC 60601-1-12, Medical Electrical Equipment - Part 1-12: General
Requirements For Basic Safety And Essential Performance -
Collateral Standard: Requirements For Medical Electrical
Equipment And Medical Electrical Systems Intended For Use In The
Emergency Medical Services Environment, Edition 1.1 2020-07
| CONSOLIDATED VERSION |
|---|
| The following quality assurance measures are applied to the development |
| of the system: Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification & Validation) Safety testing (Verification) |
| Probe materials are biocompatible. |
| Summary of Clinical Tests: |
| The subject of this premarket submission, Vscan Air, did not require |
| clinical studies to support substantial equivalence. |
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Image /page/9/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized, cursive font in the center. The circle is surrounded by a series of curved lines that resemble water droplets or waves. The logo is simple and recognizable, and it is often used to represent the company's products and services.
| Conclusion: | Based on the equipment design similarities, conformance to recognized performance standards, and performance testing, GE Healthcare considers the proposed Vscan Air to be as safe, effective, and performs in a substantially equivalent manner as the predicate device Vscan Air (K202035). |
|---|---|
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |