Who is the manufacturer of Uscan?

EchoNous, Inc. filed the 510(k) submission for Uscan (K181574).

What is the FDA product code for Uscan?

IYO. It is classified under 21 CFR 892.1560 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Uscan?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Uscan?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Uscan

Q: What are the predicate devices for Uscan?

Uscan Ultrasound System (K160420).

K181574 · EchoNous, Inc. · IYO · Jul 10, 2018 · Radiology

Device Facts

Record ID	K181574
Device Name	Uscan
Applicant	EchoNous, Inc.
Product Code	IYO · Radiology
Decision Date	Jul 10, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1560
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal. Musculoskeletal, Pediatric, Small Organ, and Peripheral Vessel. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.

Device Story

Hand-held diagnostic ultrasound system; acquires echo data via linear or annular array transducers; displays B-mode images on off-the-shelf tablet (Android OS). Includes automated bladder volume measurement feature. Used in clinical settings by trained healthcare professionals for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging; assists in needle/catheter placement. Device connects wirelessly; operates via battery. Output provides visual diagnostic information and automated measurements to support clinical decision-making and procedural guidance.

Clinical Evidence

Bench testing only. Performance evaluated via imaging performance and measurement accuracy testing. Compliance with ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, IEC 62366, ISO 14971, and NEMA UD 2-2004 standards. No clinical data presented.

Technological Characteristics

Handheld tablet-based ultrasound; 9.7" LCD; Android OS. Transducers: Linear/Annular arrays (3.0-14.0 MHz). Materials: ABS+PC, Cycoloy, Polymethyl Pentene, Silicone Rubber, TPU. Connectivity: Wireless networking, Micro USB. Power: Battery-operated. Software: App-based. Sterilization: Not specified (standard biocompatibility testing performed).

Indications for Use

Indicated for non-invasive diagnostic ultrasound imaging of the human body, specifically abdominal, musculoskeletal, pediatric, small organ (prostate), and peripheral vessel applications, including needle/catheter guidance. Also indicated for automated bladder volume measurement. Requires trained clinician use.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

Uscan Ultrasound System (K160420)

Reference Devices

SonoSite SII Ultrasound System (K162045)

Related Devices

K160420 — SpeqT · Signostics Limited · Mar 21, 2016
K232808 — Butterfly iQ3 Ultrasound System · Butterfly Network, Inc. · Jan 4, 2024
K172750 — Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) · Guangzhou Sonostar Technologies Co., Ltd. · Feb 28, 2018
K153581 — Bladder Scanner · Caresono Technology Co., Ltd. · Apr 8, 2016
K143493 — SignosRT Bladder Ultrasound System · Signostics, Ltd. · Jan 14, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 10th, 2018 EchoNous, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313 Re: K181574 Trade/Device Name: Uscan Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: June 14, 2018 Received: June 15, 2018 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jeff Rodges for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) ### K181574 Device Name Uscan ### Indications for Use (Describe) The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal. Musculoskeletal, Pediatric, Small Organ, and Peripheral Vessel. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ 510(k) Number (if known) Device Name Uscan System: ### TABLE 1.3-1: USCAN INDICATIONS FOR USE FORM Uscan | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------| | General (Track 1 Only) | Specific (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | P | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | | | | | | | | | Small Organ (Specify) | P | | | | | | 1 | | Fetal Imaging & Other | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | P | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | Cardiac | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | | | | | | 2 | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: 1: Small organ imaging is prostate. 2: Includes imaging to assist in the placement of needles and catheters in vascular structures. All items marked "P" were previously cleared in 510(k) K160420. 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. # Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {4}------------------------------------------------ 510(k) Number (if known) Device Name Uscan ### TABLE 1.3-2: USCAN INDICATIONS FOR USE FORM | System: | Uscan | |---------------|-------------------------------------------------------------| | Transducer: | Uscan Sector Probe (B3-5) | | Intended Use: | Diagnostic ultrasound imaging of the human body as follows: | | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------| | General (Track 1 Only) | Specific (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | P | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | | | | | | | | | Small Organ (Specify) | P | | | | | | 1 | | | Neonatal Cephalic | | | | | | | | | Fetal Imaging & Other | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | P | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | Cardiac | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: 1: Small organ imaging is prostate. 2: Includes imaging to assist in the placement of needles and catheters in vascular structures. All items marked "P" were previously cleared in 510(k) K160420. 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. {5}------------------------------------------------ 510(k) Number (if known) Device Name Uscan ### TABLE 1.3-3: USCAN INDICATIONS FOR USE FORM | System: | Uscan | |---------------|-------------------------------------------------------------| | Transducer: | Uscan Linear Probe (L14-6) | | Intended Use: | Diagnostic ultrasound imaging of the human body as follows: | | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------| | General (Track 1 Only) | Specific (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | Fetal Imaging & Other | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | Cardiac | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | | | | | | 2 | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E X Prescription Use (Part 21 CFR 801 Subpart D) Additional Comments: 1: Small organ imaging is prostate. 2: Includes imaging to assist in the placement of needles and catheters in vascular structures. Type of Use (Select one or both, as applicable) __ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {6}------------------------------------------------ ### 510(k) Summary #### 1. Submitter: EchoNous, Inc. 8310 154th Ave NE Bldg B. Ste 200 Redmond, WA 98052 USA #### 2. Contact Person: Trish Liau Regulatory Affairs Manager Telephone: (425) 402-4044 E-mail: patricia.liau@echonous.com #### 3. Date Prepared: March 30, 2018 - 4. Proprietary/Marketed Names: Uscan (subject to change) #### ട. Common/Usual Name: Diagnostic ultrasound system with accessories #### Classification: 6. Regulatory Class: II Review Category: Tier II Classification Panel: Radiology | Name | 21 CFR Number | Product Code | |---------------------------------------|---------------|--------------| | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | #### 7. Predicate Devices: Primary predicate: Uscan Ultrasound System (K160420) Reference predicate: SonoSite SII Ultrasound System (K162045) #### Device Description: 8. The Uscan is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode on an off-the-shelf display. Automated bladder volume measurements are supported. {7}------------------------------------------------ #### 9. Intended Use: The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, Small Organ, and Peripheral Vessel. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume. #### 10. Technological Characteristics: The Uscan and SII ultrasound systems are Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below. | Feature | Uscan Ultrasound System (This submission) | Uscan Ultrasound System (K160420) | SonoSite SII Ultrasound System (K162045) | |---------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Diagnostic ultrasound imaging of the human body | Diagnostic ultrasound imaging of the human body | Diagnostic ultrasound imaging or fluid flow analysis of the human body | | Indications for Use | Abdominal Pediatric Small Organ (prostate) | Abdominal Pediatric Small Organ (prostate) | Opthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-Rectal Trans-Vaginal | | | Musculo-skeletal (Conventional) | Musculo-skeletal (Conventional) | Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel Needle guidance | | | Peripheral Vessel Needle guidance | | | | Transducer Types | Linear Array | Annular Array | Linear Array Curved Linear Array Intracavitary Phased Array | | Transducer Frequency | 3.0 - 14.0 MHz | 3.0 - 7.0 MHz | 1.0 - 15.0 MHz | | Modes of Operation | 2D / B-mode | 2D / B-mode | 2D / B-mode Tissue Harmonic Imaging M-mode Color M-mode Color Power Doppler Combination Modes Velocity Color Doppler | | PW Doppler | Not available | Not available | Not available | | CW Doppler | Not available | Not available | Not available | | Feature | Uscan Ultrasound System (This submission) | Uscan Ultrasound System (K160420) | SonoSite SII Ultrasound System (K162045) | | Patient Contact Materials | Transducers: ABS+PC (acrylonitrile butadiene styrene + polycarbonate) | Transducers: | Transducers: Acrylonitrile-butadiene- styrene (ABS) | | | Cycoloy | Cycoloy | Cycoloy Polycarbonate (PC) | | | Polymethyl Pentene based Olefin Copolymer | Polymethyl Pentene based Olefin Copolymer | Polymethyl Pentene based Olefin Copolymer | | | Silicone Rubber RTV Thermoplastic polyurethane | Thermoplastic polyurethane | Polysulfone Poly-Vinyl-Chloride (PVC) Silicone Rubber Silicone Rubber RTV | | | | | Urethane Needle Guides: Acetal copolymer Acrylonitrile-butadien-styrene (ABS) | | System Characteristics | Uscan: Handheld tablet (off-the-shelf) 9.7" Liquid Crystal Display (LCD) Operating system: Android | Uscan: Handheld tablet (off-the-shelf) 7.86" Liquid Crystal Display (LCD) Operating system: Android | SII: Handheld display and control 12.1" Liquid Crystal Display (LCD) Operating system: Windows CE | | | Uscan ultrasound software running as an "app" on tablet | Uscan ultrasound software running as an "app" on tablet | | | | 1 Micro USB port | 1 Micro USB port | 3 USB ports | | | Dimensions: 9.34"(H) x 6.65"(W) x 0.24"(L) Weight: 0.39 lbs | Dimensions: 8.15"(H) x 5.39"(W) x 0.31"(L) Weight: 0.77 lbs | Dimensions: 4.8"(H) x 11.5"(W) x 17.6"(L) Weight: 12.6 lbs | | | System operates via battery | System operates via battery | System operates via battery or AC power | | | Input: 100-240 VAC, 50/60 Hz Output: 5VDC, 2 A max | Input: 100 - 240 VAC, 50/60 Hz Output: 12VDC, 1.5 A max | Input: 100 - 240V options, 50/60 Hz Output: 15VDC | | | Distance calculations | Distance, volume calculations | Various obstetrical, cardiac, volume, and M-mode measurement and calculation packages | | | Wireless networking | Wireless networking | Wireless networking | | 510(k) Track | Track 3 | Track 3 | Track 3 | {8}------------------------------------------------ {9}------------------------------------------------ #### 11. Basis for Substantial Equivalence: ### Summary of Non-Clinical Tests The Uscan has been designed and evaluated to comply with the following FDA recognized standards. | Reference No. | Title | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process | | IEC 60601-1 | AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | | IEC 60601-1-2 | AAMI / ANSI / IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | | IEC 60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | IEC 60601-2-37 | IEC 60601-2-37:2015 Edition 2.1, Medical electrical equipment – Part 2- 37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | | IEC 62304 | AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycle processes | | IEC 62366 | AAMI / ANSI / IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical devices | | ISO 14971 | ISO 14971:2007, Medical devices - Application of risk management to medical devices | | NEMA UD 2-2004 | NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | The Uscan has been bench tested for imaging performance and measurement accuracy, with tests showing the Uscan imaging performance and measurement accuracy to be substantially equivalent to the predicate devices. Verification and validation reports, traceability, and risk analysis demonstrate the Uscan operates as intended and risks mitigated have been verified. The conclusion from the testing is the device is safe and effective for its intended use, and performs as well or better than the predicate devices. The Uscan system and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards. EchoNous, Inc. believes the Uscan is substantially equivalent with regard to safety and effectiveness to the predicate devices.