Butterfly iQ3 Ultrasound System

K232808 · Butterfly Network, Inc. · IYN · Jan 4, 2024 · Radiology

Device Facts

• Record ID: K232808
• Device Name: Butterfly iQ3 Ultrasound System
• Applicant: Butterfly Network, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jan 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies). Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Procedural Guidance, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler, Fetal Heart Sounds, B-mode + Biplane, B-mode + Needle Viz Tool, B-mode + Biplane + Needle Viz Tool, B-mode + Multi-Slice, and B-mode + Sweep. The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic. hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.

Device Story

Portable, hand-held diagnostic ultrasound system; consists of single CMUT array transducer connected via USB to COTS mobile device (iOS/Android). Operates in B-mode, M-mode, Color/Power/Spectral Doppler, and specialized modes (Biplane, Needle Viz, Multi-Slice, Sweep). Used by healthcare professionals/students in hospitals, clinics, home, or emergency settings. Provides real-time imaging/measurement for anatomical visualization. Output displayed on mobile device interface; supports clinical decision-making via diagnostic visualization and automated tools (B-lines, bladder volume). Benefits include portability and broad imaging capabilities for diverse clinical environments.

Clinical Evidence

Bench testing only; no clinical studies required for this submission. Verification and validation activities confirmed device meets performance specifications and design requirements.

Technological Characteristics

Capacitive micromachined ultrasonic transducer (CMUT) array; 1.0-12 MHz frequency range. Battery-operated; direct contact charging. Lens material: butadiene synthetic rubber. Connectivity: USB to COTS mobile device (iOS/Android). Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-12, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1/5/10, ISO 14971.

Indications for Use

Indicated for diagnostic ultrasound imaging and measurement of anatomical structures and fluids in adult and pediatric patients. Clinical applications: peripheral vessel, small organs, cardiac, abdominal, lung, procedural guidance, urology, fetal/obstetric, gynecological, musculoskeletal, and ophthalmic.

Regulatory Classification

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.

Predicate Devices

• Butterfly iQ/iQ+ Ultrasound System (K220068)

Submission Summary (Full Text)

{0}------------------------------------------------

January 4, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Butterfly Network, Inc. % Nathan Sabich Senior Director, Head of Global Regulatory Affairs 1600 District Ave BURLINGTON MA 01803

# Re: K232808

Trade/Device Name: Butterfly iQ3 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: December 1, 2023 Received: December 4, 2023

Dear Nathan Sabich:

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.

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).

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

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.

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.

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# Indications for Use

Submission Number (if known)

K232808

Device Name

Butterfly iQ3 Ultrasound System

Indications for Use (Describe)

The iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications:

Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies). Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Procedural Guidance, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic.

Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler, Fetal Heart Sounds, B-mode + Biplane, B-mode + Needle Viz Tool, B-mode + Biplane + Needle Viz Tool, B-mode + Multi-Slice, and B-mode + Sweep.

The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic. hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.

Type of Use (Select one or both, as applicable)

> | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

# 510(k) Summary of Safety and Effectiveness Butterfly Network, Inc.

# K232808

This 510(k) summary is submitted in accordance with 21 CFR Part 807.92:

Date Prepared: September 8, 2023

#### Submitter Name and Address:

Butterfly Network, Inc. 1600 District Ave Burlington, MA 01803 Phone: [phone]

# Primary Contact:

Nathan Sabich Senior Director, Head of Global Regulatory Affairs E-mail: [e-mail]

#### Subject Device - Proprietary/Trade Name:

Butterfly iQ3 Ultrasound System

#### Subject Device - Common/Usual Name:

Diagnostic Ultrasound Imaging System

#### Device Classification:

Class II

#### Regulation Description:

| Classification Name(s) | Regulation Number | Product Code |
|---------------------------------------------------|-------------------|--------------|
| Primary | | |
| Ultrasonic Pulsed Doppler Imaging System | 21 CFR 892.1550 | IYN |
| Secondary | | |
| Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 | ITX |
| Medical Image Management and Processing<br>System | 21 CFR 892.2050 | QIH |

{4}------------------------------------------------

#### Predicate Device Information:

| Device Trade Name: | Butterfly iQ/iQ+ Ultrasound System |
|----------------------------|------------------------------------------|
| 510(k) Number: | K220068 |
| Submitter: | Butterfly Network, Inc. |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging System |
| Primary Product Code: | IYN - 21 CFR 892.1550 |
| Secondary Product Code(s): | IYO - 21 CFR 892.1560 |
| | ITX – 21 CFR 892.1570 |
| | QIH – 21 CFR 892.2050 |

Note: The predicate device has not been subject to a design-related recall.

# Device Description:

The Butterfly iQ3 Ultrasound System is a portable, hand-held, general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid on adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected via a USB cable to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode and B-mode imaging the instrument also supports Color Flow Doppler imaging.

The user interface includes touch screen menus, buttons, controls, indication icons that allow the operator to control the system and to view and measure ultrasound imagerv.

# Indications for Use:

The Butterfly iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diaqnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications:

Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Procedural Guidance, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic.

Modes of operation include B-mode + M-mode. B-mode + Color Doppler. B-mode + Power Doppler, Spectral Pulsed Wave Doppler, Fetal Heart Sounds, B-mode + Biplane, B mode + Needle Viz Tool, B-mode + Biplane + Needle Viz Tool, B-mode + Multi-Slice, B-mode + Sweep.

The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic, hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.

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

# Summary of Technological Characteristics:

There are no technological characteristics and features that change the indications for use in this submission that are not previously evaluated and cleared in the predicate device. The iQ3 represents a new Butterfly iQ App compatible transducer.

As with the iQ and iQ+, the iQ3 uses a capacitive micromachined ultrasonic transducer (CMUT) array rather than a traditional crystalline piezoelectric array. The system remains battery operated and all image interaction and capture is with the existing iOS and Android host applications. The Bladder Volume and B-lines tools remain compatible with the images generated with the iQ3.

As with the iQ+. the iQ3 includes new printed circuit board assemblies and a next generation release of the CMUT array. Additionally, the iQ3 uses a new custom battery, a new lens material (butadiene synthetic rubber), and replaces the induction coil charging method with a direct contact charqing system.

# Summary of Safety and Non-Clinical Performance:

The Butterfly iQ3 Ultrasound System was developed and tested in accordance with internal procedures for safety, design quality, and documentation.

Verification and validation activities were designed and performed to demonstrate that the Butterfly iQ3 Ultrasound System meets predetermined performance specifications. The following standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the safe and effective performance of the device:

| IEC 60601-1 Ed. 3.2<br>en: 2020 | Medical Electrical Equipment - Part 1. General<br>requirements for basic safety and essential performance |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-11 Ed.<br>2.1 b:2020 | Medical electrical equipment - Part 1-11: General requirements<br>for basic safety and essential performance - Collateral Standard:<br>Requirements for medical electrical equipment and medical<br>electrical systems used in the home healthcare environment<br>CONSOLIDATED EDITION |
| IEC 60601-1-12 Ed.<br>1.1 b:2020 | Medical electrical equipment - Part 1-12: General requirements<br>for basic safety and essential performance - Collateral Standard:<br>Requirements for medical electrical equipment and medical<br>electrical systems intended for use in the emergency medical<br>services environment CONSOLIDATED EDITION |
| IEC 60601-1-2:<br>2014/AMD1:2020 | Medical Electrical Equipment – Part 1-2: General requirements<br>for basic safety and essential performance – Collateral<br>Standard: Electromagnetic disturbances - Requirements and<br>tests |

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

| IEC 60601-2-37 Ed.<br>2.0 b: 2007 | Medical Electrical Equipment – Part 2-37. Particular<br>requirements for the basic safety and essential performance of<br>ultrasonic medical diagnostic and monitoring equipment<br>CONSOLIDATED EDITION |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1 | Biological evaluation of medical devices — Part 1: Evaluation<br>and testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization |
| ISO 14971:2019 | Application of risk management to medical devices |

Software Verification and Validation Testing for the Butterfly iQ3 Ultrasound System was also conducted and provided in accordance with recommended FDA guidance documentation for Industry and FDA Staff.

Relevant non-clinical verification and validation testing was performed to address the introduction of the subject hardware and its compatibility with the cleared Butterfly iQ App and to assure its safe and effective performance. Verification and validation testing established that the device meets its design requirements, intended use, and demonstrates substantial equivalence to the predicate.

# Summary of Clinical Tests:

The Butterfly iQ3 Ultrasound System did not require clinical studies to support substantial equivalence for this premarket submission.

# Summary of Substantial Equivalence:

The Butterfly iQ3 Ultrasound System is substantially equivalent to the predicate device (K220068). The following table below provides an overview of the comparison between the subject device and the predicate device.

| Model | Butterfly iQ3<br>Ultrasound<br>System (Subject<br>Device) | Butterfly iQ/iQ+<br>Ultrasound System<br>(K220068,<br>Predicate Device) | Comparison |
|------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------|----------------------|
| Regulatory Information | | | |
| Regulation Number | 892.1550 | 892.1550 | Remains<br>Unchanged |

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

| Device Classification<br>Name | Ultrasonic Pulsed<br>Doppler Imaging<br>System | Ultrasonic Pulsed<br>Doppler Imaging<br>System | Remains<br>Unchanged |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Remains<br>Unchanged |
| Product Codes | IYN<br>IYO<br>ITX<br>QIH | IYN<br>IYO<br>ITX<br>QIH | Remains<br>Unchanged |
| Intended Use | | | |
| Intended for use by<br>qualified and trained<br>healthcare professionals<br>to enable diagnostic<br>ultrasound imaging and<br>measurement of<br>anatomical structures and<br>fluids of adult and<br>pediatric patients. | ✓ | ✓ | Remains<br>Unchanged |
| General Device Description | | | |
| Hand-held portable<br>diagnostic ultrasound<br>system. | ✓ | ✓ | Remains<br>Unchanged |
| Indications for Use | | | |
| Abdominal | ✓ | ✓ | Remains<br>Unchanged |
| Cardiac | ✓ | ✓ | Remains<br>Unchanged |
| Lung | ✓ | ✓ | Remains<br>Unchanged |
| Musculoskeletal<br>(conventional and<br>superficial) | ✓ | ✓ | Remains<br>Unchanged |
| Fetal/Obstetric,<br>Gynecological | ✓ | ✓ | Remains<br>Unchanged |
| Peripheral Vessel<br>(including carotid, deep<br>vein thrombosis, arterial<br>studies) | ✓ | ✓ | Remains<br>Unchanged |
| Procedural Guidance | ✓ | ✓ | Remains<br>Unchanged |
| Small Organs<br>(including thyroid,<br>scrotum, and breast) | ✓ | ✓ | Remains<br>Unchanged |
| Urology | ✓ | ✓ | Remains<br>Unchanged |
| Opthalmic | ✓ | ✓ | Remains<br>Unchanged |
| Imaging Modes/Tools | | | |
| M-Mode | ✓ | ✓ | Remains<br>Unchanged |
| B-Mode (2D) | ✓ | ✓ | Remains<br>Unchanged |
| Color Doppler | ✓ | ✓ | Remains<br>Unchanged |
| Pulsed Wave Doppler | ✓ | ✓ | Remains<br>Unchanged |
| 3-D | ✓ | ✓ | Remains<br>Unchanged |
| Harmonic Imaging | ✓ | ✓ | Remains<br>Unchanged |
| Fetal Heart Sounds | ✓ | ✓ | Remains<br>Unchanged |
| B-mode + Biplane | ✓ | ✓ | Remains<br>Unchanged |
| B-mode + Needle Viz<br>Tool | ✓ | ✓ | Remains<br>Unchanged |
| B-mode + Biplane +<br>Needle Viz Tool | ✓ | ✓ | Remains<br>Unchanged |
| B-mode + Multi-Slice | ✓ | - | Multi-slice<br>collects and<br>displays B-<br>mode images<br>from different<br>angles<br>separately. This<br>new mode does<br>not change the<br>acoustic output<br>to the normal<br>B-Mode or 3-D<br>image, nor<br>does it<br>introduce any<br>new questions<br>of safety and<br>effectiveness. |
| B-mode + Sweep | ✓ | - | Sweep collects<br>and<br>continuously<br>displays B-<br>mode images<br>from different<br>angles. This<br>new mode does<br>not change the<br>acoustic output<br>to the normal<br>B-Mode or 3-D<br>image, nor<br>does it<br>introduce any<br>new questions<br>of safety and<br>effectiveness. |
| <b>Transducer</b> | | | |
| Type | Single probe 2D<br>Phased Array | Single probe<br>2D Phased<br>Array | Remains<br>Unchanged |
| Frequency | 1.0 - 12 MHz | 1.0 - 10 MHz | Similar. The subject device remains within the boundaries of the predicate device and does not introduce any new questions of safety and effectiveness. |
| Software Features | | | |
| Auto B-Lines Counter | ✓ | ✓ | Remains Unchanged |
| Auto Bladder Volume | ✓ | ✓ | Remains Unchanged |
| Patient Data Entry | ✓ | ✓ | Remains Unchanged |
| Patient Database and Storage | ✓ | ✓ | Remains Unchanged |
| Generic Measurement Tools | ✓ | ✓ | Remains Unchanged |
| Analysis and Calculation Packages | ✓ | ✓ | Remains Unchanged |
| Annotations | ✓ | ✓ | Remains Unchanged |
| Other | | | |
| Target Population | Adult and Pediatric | Adult and Pediatric | Remains Unchanged |
| Device Use Settings | Professional healthcare facilities (e.g. Hospital, clinic, hospice, or medical office) | Professional healthcare facilities (e.g. Hospital, clinic, hospice, or medical office), home healthcare | Remains Unchanged |
| | home healthcare<br>environment,<br>ambulances<br>and/or accident<br>sites, and other<br>environments<br>where healthcare<br>is provided. Users<br>may also include<br>medical students<br>working under the<br>supervision or<br>authority of a<br>physician during<br>their education/<br>training. | environment,<br>ambulances and/or<br>accident sites, and<br>other environments<br>where healthcare is<br>provided. Users<br>may also include<br>medical students<br>working under the<br>supervision or<br>authority of a<br>physician during<br>their education/<br>training. | |
| Energy<br>used/delivered<br>(MI/TI) | Acoustic will<br>meet<br>FDA/AIUM<br>guidelines | Acoustic will<br>meet<br>FDA/AIUM<br>guidelines | Remains<br>Unchanged |
| Portable/hand-held | ✓ | ✓ | Remains<br>Unchanged |
| Biocompatibility | ✓ | ✓ | Remains<br>Unchanged |
| Sterility | Products not<br>classified as sterile | Products not<br>classified as sterile | Remains<br>Unchanged |
| Cleaning/Reprocessing<br>Methods | ✓ | ✓ | Remains<br>Unchanged |
| Electrical safety | Meets electrical<br>safety standards<br>for a class II<br>medical device.<br>Group 1<br>Class B (CISPR) | Meets electrical<br>safety standards<br>for a class II<br>medical device.<br>Group 1<br>Class B (CISPR) | Remains<br>Unchanged |
| Mechanical safety | Will meet<br>mechanical safety<br>standards for a<br>class II medical<br>device | Will meet<br>mechanical safety<br>standards for a<br>class II medical<br>device | Remains<br>Unchanged |
| Display | COTS device<br>display | COTS device<br>display | Remains<br>Unchanged |
| Power requirements | Battery | Battery | Remains<br>Unchanged |
| Real-time Image…