UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K133329
• Device Name: UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SAMSUNG MEDISON CO., LTD
• Date Cleared: 2013-11-27 ( 29 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K112339 , K130803 , K103397 , K130739 , K093563
• Predicate For: K141620 , K143089 , K143264

Intended Use

The UGEO WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Small Organs, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial) and Peripheral vessel.

Device Description

The UGEO WS80A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode. M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode: S-Flow), PW Spectral Dopler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The UGEO WS80A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO WS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

The provided 510(k) Premarket Notification for the UGEO WS80A Diagnostic Ultrasound System (K133329) does not contain specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy, or other quantitative measures) nor does it describe a study designed to prove the device meets such criteria.

Instead, this submission is a Premarket Notification focused on demonstrating substantial equivalence to existing legally marketed devices. As such, the "study" proving the device meets criteria is primarily a comparison of technological characteristics and intended uses to predicate devices.

Here's a breakdown of the requested information based on the provided document:

---

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no specific quantitative acceptance criteria or performance metrics are provided in this regulatory submission. The "reported device performance" is implicitly that it performs equivalently to the listed predicate devices across various features and intended uses.

Feature / Characteristic	Acceptance Criteria (Not explicitly stated in quantitative terms)	Reported Device Performance
Intended Uses	Substantially equivalent to predicate devices (ACCUVIX A30, UGEO HM70A, ACCUVIX XG, ACUSON S2000, iU22) for listed clinical applications.	The UGEO WS80A supports Fetal, Abdominal, Small Organs, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), and Peripheral vessel imaging, which is shown to be consistent with or an expansion of predicate device capabilities.
Modes of Operation	Substantially equivalent to predicate devices for B-mode, M-mode, PW Doppler, Color Doppler, Power Amplitude Doppler, Tissue Harmonic Imaging, 3D/4D imaging, Combined modes.	The UGEO WS80A supports all these modes, demonstrating equivalence to the listed predicate devices.
Safety & EMC Compliance	Conformance to international and national safety and EMC standards (UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, EN/IEC 60601-1, EN/IEC 60601-1-2, NEMA UD-2, NEMA UD-3, ISO10993-1, ISO14971).	The device was evaluated and found to conform to all listed applicable standards. (See Section 7: "A brief discussion of the bench and non-clinical tests conducted on the subject device").
Functionality (e.g., Quick Scan, Auto IMT+, Elastoscan, 5D Cine, 5D LB, MPI)	Substantially equivalent to specified functionalities found in predicate devices.	The UGEO WS80A incorporates various advanced functionalities (e.g., Q Scan, SMDR (SMDR evo), Auto IMT+ (Auto IMT), Elastoscan, Panoramic, 3D Imaging, 5D Cine, 5D NT, 5D LB, MPI) in a manner equivalent to or in some cases enhanced from the predicate.
Transducer Compatibility	Ability to operate with the listed transducers (SC1-6, C2-6, E3-12A, VR5-9, L3-12A, L5-13, V4-8, V5-9) for specified clinical applications and modes.	Each transducer listed is cleared for specific clinical applications and modes of operation, demonstrating its intended functionality with the UGEO WS80A system.

---

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, UGEO WS80A, did not require clinical studies to support substantial equivalence."

Therefore, there was no "test set" in the sense of clinical image data used for performance evaluation that would have a sample size or data provenance. The assessment was based on technical specifications and comparison to predicate devices.

---

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical studies or test sets requiring expert-established ground truth were deemed necessary, this information is not applicable and not provided in the submission.

---

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring adjudication was used.

---

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool for which MRMC comparative effectiveness studies comparing human readers with and without AI assistance are typically conducted.

---

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The UGEO WS80A is a diagnostic ultrasound system operated by a human, not a standalone algorithm. While it features some automated measurement and imaging functions (e.g., 5D Cine, 5D NT, Auto IMT+), these are features of the overall system, and their standalone "algorithm performance" is not separately reported in this regulatory documentation. The focus is on the substantial equivalence of the system as a whole.

---

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical studies requiring ground truth were performed. The "ground truth" for demonstrating substantial equivalence relied on technical specifications, functional comparisons, and adherence to recognized safety standards in comparison to legally marketed predicate devices.

---

8. The sample size for the training set

Not applicable. Since no clinical studies were performed, there was no "training set" of data in the context of machine learning or AI development.

---

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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

K133329

510(k) Premarket Notification

UGEO WS80ADiagnostic Ultrasound System

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E. Section 807.92.

1. Submitter's Information: 21 CFR 807.92(a)(1)

SAMSUNGMEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea

Contact Person: Kyeong-Mi, Park Regulatory Affairs Manager

Telephone: [phone] Facsimile: 82.2.556.3974

Data Prepared: September 2, 2013

2. Name of the device:

Common/Usual Name: Diagnostic Ultrasound System and Accessories Proprietary Name: UGEO WS80A Diagnostic Ultrasound System Classification Names: Product Code FR Number Ultrasonic Pulsed Doppler Imaging System 892.1550 IYN Ultrasound Pulsed Echo Imaging System 892.1560 IYO Diagnostic Ultrasound Transducer 892.1570 ITX

3. Identification of the predicate or legally marketed device:

• ACCUVIX A30 Diagnostic Ultrasound System(K112339) .
• UGEO HM70A Diagnostic Ultrasound System(K130803) -
• -ACCUVIX XG Diagnostic Ultrasound System (K103397)
• ACUSON S2000 Diagnostic Ultrasound System (K130739) -
• iU22 Diagnostic Ultrasound System (K093563) -
• • The proprietary name of predicate device (K130803) was changed to UGEO HM70A Diagnostic Ultrasound System from UGEO H70c Diagnostic Ultrasound System on FDA Databases .

510(k) Summary / Statement Certification

ATTACHEMENT 1

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

··············································································································································································

4. Device Description:

The UGEO WS80A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode. M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode: S-Flow), PW Spectral Dopler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The UGEO WS80A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO WS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

5. Intended Uses:

The UGEO WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal, Abdominal, Small Organs, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial) and Peripheral vessel.

6. Technological Characteristics:

The UGEO WS80Ais substantially equivalent with respect to safety, effectiveness, and functionality to the ACCUVIX A30 Diagnostic Ultrasound System (K112339) and UGEO HM70A Diagnostic Ultrasound System (K130803).

It is substantially equivalent with respect to safety, effectiveness, and functionality to the [3D Cine. HDVI and Volume NT | of SAMSUNG MEDISON's UGEO HM70A (K 130803) in regards to the device with [5D Cine'), FRV2), 5D NT31 and 2D NT+1].

It is substantially equivalent with respect to safety, effectiveness, and functionality to the [Syngo Auto OB Measurements] of Siemens's ACUSON S2000 (K130739) in regards to the device with [5D LB (Long Bone) 3).

It is substantially equivalent with respect to safety, effectiveness, and functionality to the High O Automatic Doppler Analysis] of Philips's iU22 (K093563) in regards to the device with [MP16].

All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

These are described in detail in the technological characteristics comparison table as below.

510(k) Summary / Statement Certification

ATTACHEMENT 1

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. ・・・

	The subjectdevice	The predicate devices
Feature / Characteristics、ジ11	UGEO WS80A	ACCUVIXA30(K112339)	UGEOHM70A(K130803)	ACCUVIXXG(K103397) .	ACUSONS2000 -(K130739)	iU22(K093563)
Indication for Use
- Fetal	ﺮ	4	-	ﮯ	2	ﮨﯿﮯ
- Abdominal	イ	ど	V	1	4	ﺮ ﺳ
- Pediatric		V	ﺳ	4	イ	2
- Small Organ	ﯿﮯ	ﮯ	ಳ	ਪ੍ਰ	V	ﮨﮯ۔
- Neonatal Cephalic		ど	ﮨﮯ	ど	ﮨﮯ	ﯿﮯ
- Adult Cephalic		4	1	く	←	2
- Trans-rectal	ﻳﻢ	ん	く	ﮨﮯ	V	1
- Trans-vaginal	ﻴﻢ	2	ﺮ ﻣﺤﻤﺪ ﺍﻟﻤﺴﺘﻌﻤﺎﺭ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟ	ಲ್ಲ	V	ﻳﺴ
- Musculo-skeletal
(Conventional)	ly	イ	ﺮ ﺍﻟﻤﺴﺘﻤﺮ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﺸﻤﻞ ﺍﻟﻤﺴﺘﺸﻤﻞ ﺍﻟﻤﺴﺘﺸﻤﻞ ﺍﻟﻤﺴﺘﺸﻤﻞ ﺍﻟﻤﺴﺘﺸﻤﻞ ﺍﻟﻤﺴﺘﺸﻤﻞ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘ	V	V	ゾ
- Musculo-skeletal(Superficial)	r	く	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	V	v	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Cardiac Adult		ﮯ	-	ど	V	ﯿﺴ
		イ	ﺳ	2	イ	V
- Cardiac Pediatric		4	V	く	V	V
- Peripheral vessel	ريم
Scanhead Types	ﯾﮯ	2	ﮨﮯ	ﮨﮯ	4	ﮨﮯ
- Linear Array	イ		-	ﮯ	4	ﻢ
- Curved Linear Array		ﮨﮯ	1	ﮯ	く
- Endocavity	4	4				1
- Phased Array		ਪ	ﻳﻢ	ﮯ	く	V
- Static Probes		ﮯ	ﻣﯿﺮ	ど	1	ﯾﮯ
Scanhead Frequency
1.0~20.0 MHz	V	V	V	く	4	ﮯ
Modes of Operation
- B-mode	ど	ﮯ	ﮨﮯ	イ	V	ﺮﻳﺴﻤﺎ
- M-mode	V	2	ど	2	く	バ
- Pulsed wave (PW)Doppler	y	ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー	ﺮ ﺍ	-	V	く
- Continuous wave (CW)Doppler		-	ﺃ	ત્	V	1
- Color Doppler	2	4	V	イ	V	V
- Power AmplitudeDoppler	1	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	ﺮﻳﺲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ	V	ﮯ	V
- Tissue Harmonic	V	V	く	V	4	ﺮﻳﻢ ﺍﻟﻤﺴﻠﺴﻞ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
Imaging	ಳ		ﭘﯿ		V
- 3D/4D imaging mode	l	2	V	ﮯ		ﯾﺴ2
- Combined modes		V		V	ど
Safety & EMC Compliance
- IEC 60601-1	ﮨﮯ۔	v	v	v	-	-
- UL 60601-1
- CSA C22.2 No.601.1
- IEC 60601-2-37	1	2	V	V	V	4
- IEC 60601-1-2Acoustic Output Display Standard	V	ﮯ	ﻴﺴ	ど	ﮨﮯ۔	ﻤﯿﮟ

510(k) Summary / Statement Certification

ATTACHEMENT 1

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

..............................................................................................................................................................................

·

・

UGEO WS80ADiagnostic Ultrasound System

. , .

Feature / Characteristics	The subject deviceUGEO WS80A	ACCUVIX A30(K112339)	UGEO HM70A(K130803)	ACCUVIX XG(K103397)	ACUSON S2000(K130739)	iU22(K093563)
Track 3	√	√	√	√	√	√
Patient Contact Materials
Tested to ISO 10993-1	√	√	√	√	√
Functionality
- Quick Scan (Q Scan)	√	√	√	√
- Spatial Compound Imaging		√		√
- SMDR (SMDR evo)	√	√	√	√
- Auto IMT+(Auto IMT)	√	√	√	√
- Elastoscan	√	√	√	√
- Panoramic	√	√	√	√
- 3D Imaging(Volume Data Acquisition)	√	√	√	√
- 3D Imaging presentation
3D Cine/4D Cine		√	√	√
5D Cine	√(1)
- 3D RenderingMPR(Multi Planer Render)	√	√	√	√
- 3D XIMSV(Multi Slice View)	√	√		√
Oblique View
- 3D MXIVolume Slice, Mirror View	√	√	√	√
- 3D MagiCut	√	√	√	√
- Volume Calculation(VOCAL, XI VOCAL)	√	√	√	√
- XI STIC	√	√	√	√
- HDVI	√	√	√	√
- FRV	√(2)
- Volume NT/IT	√	√	√	√
- 5D NT	√(3)
- 2D NT	√(4)
- ADVR	√	√	√	√
- 5D LB	√(5)				√(5)
MPI	√(6)					√(6)

ATTACHEMENT 1 ·

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

510(k) Premarket Notification

7. A brief discussion of the bench and non-clinical tests conducted on the subject device

The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.

The UGEO WS80A and its application comply with voluntary standards as below:

• UL 60601-1, Safety requirements for Medical Equipment
• CSA C22.2 No. 601.1. Safety requirements for Medical Equipment
• IEC60601-2-37. Diagnostic Ultrasound Safety Standards
• EN/IEC60601-1,Safety requirements for Medical Equipment
• EN/IEC60601-1-2.EMC requirements for Medical Equipment
• NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
• NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• ISO10993-1. Biocompatibility
• ISO14971, Application of risk management to medical devices

Summary of Clinical Tests:

Not applicable. The subject of this submission, UGEO WS80A, did not require clinical studies to support substantial equivalence.

8. Conclusion

Intended uses and other key features are consistent with traditional practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the UGEO WS80Ato be as safe, as effective, and performance is substantially equivalent to the predicate devices.

END of 510(K) Summary

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms, possibly representing care or protection.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

November 27, 2013

Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K133329

Trade/Device Name: UGEO WS80A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 28, 2013 Received: October 29, 2013

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, 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.

This determination of substantial equivalence applies to the following transducers intended for use with the UGEO WS80A Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
SC1-6	C2-6	E3-12A
VR5-9	L3-12A	L5-13
V4-8	V5-9

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.

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

ﯽ

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

SIO(k) Premarket Notification

UGEO WS80A Diagnostic Ultrasound System

SECTION 1.3 INDICATIONS FOR USE

510(k) Number (if known): _K133329

Device Name: UGEO WS80A Diagnostic Ultrasound System

Indications for Use:

The UGEO WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal, Abdominal, Small Organ, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial) and Peripheral vessel

Prescription Use (Part 21 CFR 80) Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sinh

(Division Sign Off) Division of Radiological Health Office of In I itro Diagnostic and Radiological Health

K133329 510(k)_

Indication for use

page 1 of10

{8}------------------------------------------------

510(k) No .:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	N	N	N		N	Note 1	Notes 2, 4, 7, 8, 11
	Abdominal (See Note 10)	N	N	N		N	Note 1	Notes 2, 7, 8, 9, 11, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	Note 1	Notes 2, 7, 8, 11, 12
	Trans-vaginal	N	N	N		N	Note 1	Notes 2, 7, 8, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Other (spec.)

N= new indication: P= previously cleared by FDA K122583: F= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note I: B+M, B+PW, B+C, B+PD, B+PPI, B+TD, B+C+PW, B+PD+PW, B+PPI+PW, B+TD+PW, B+TD+PW, B+C+M, Dral/Quad, B+E Note 2: Includes imaging for guidance of biopsy

Note 3. Includes infertility monitoring of follicle development

Device Name:UGEO WS80ADiagnostic Ultrasound System

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 8: JD immging
Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note II: Panoramic imaging

Note 12: ElastoScan

Concurrence of CDRH. Office of in I'uro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801 109)

Indication for use

page 2 of 10 .

{9}------------------------------------------------

510(k) No.:

中心

Device Name: SC1-6for use with UGEO WS80A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes2, 4, 7, 8, 11
	Abdominal/(See Note 10)	P	P	P		P	Note I	Notes2, 7, 8.9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K 130803; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

induall Comments:
Color Dopler includes Pover, (Ampinde) Doppler
Note I: B+M, B+PW, B+DD, B+PD, B+PPI, B+PD+PW, B+PD+PW, B+PP++PW, B+PP++PW, B+TD+PW, B+C+M, Dwl/Qwd(B,
B+

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5. For example: thereid, parathyroid, breast, scrotum and penis in adult, pediating and neonatal patients

Note 6 Abdominal organs and peripheral vessel

Note 7 Tissue Harmonic Imaging (THI)

Note 8. 3D imaging

Note 9. Spaiial Compound Imaging

Note 10: Includes Renal. Gynecology/Pelvis

Note II: Panoramic imaging

Note 12: ElastoScan

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR B01.109)

Indication for use

page 3 0910

{10}------------------------------------------------

510(k) No.:

Device Name: C2-6 for use with UGEO WS80A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other(Spec.)
(Track I only)	(Tracks I & 111)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note I	Notes 2, 4, 7, 8, 11
	Abdominal(See Note 10)	P	P	P		P	Note !	Notes 2, 7, 8, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication: P= previously cleared byFDA K130803; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note L: B+M, B+PW, B+C, B+PD, B+PPI, B+TD, B+C+PW, B+PD+PW, B+PP+PW, B+PP+PW, B+TD+PW, B+C+M, Dxd/Qual(B. B+C. B+PD, B+TD, B+PPI, B+PD), B+E

Note 2: Includes imaginy for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note S: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal palients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal. Gyzecology/Peivis

Note 11: Panoramic imaging

Note 12: ElastoScan

Concurrence of CDRH, Office of In I'irro Diagnostics and Radiological Health (OIR) Prescription Use (Per 2) CFR 801.109)

Indication for use

page 4 0/10

{11}------------------------------------------------

510(k) No.:

Device Name: E3-12Afor use with UGEO WS80A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation ("includes simultaneous B-mode)
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	N	N	N		N	Note 1	Notes 7, 8
	Abdominal(See Note 10)	N	N	N		N	Note 1	Notes 7, 8, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	Note 1	Notes 7, 8, 12
	Trans-vaginal	N	N	N		N	Note 1	Notes 7, 8, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

ലംബ മാറ്റിം, B+C, B+PD, B+PD, B+PPI, B+TD, B+C+PW, B+PD+PW, B+PP+PW, B+PP+PW, B+C+M, Dml/Qmd(B, B+C, B+PD, B+TD, B+PPI, B+PD), B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrown and penis in adult, pediatric and neonated patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9, Spatial Compound Imaging

Note 10 Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Concurrence of CDRH, Office of in Virro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indication for use

page 5 0110

{12}------------------------------------------------

....

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: VR5-9for use with UGEO WS80A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note I	Note 2, 7, 8
	Abdominal (See Note 10)	P	P	P		P	Note I	Note 2, 7, 8, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note I	Note 2, 7, 8, 12
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convert.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K 103397: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Doppier includes Power ( Amplinde) Doppler
Note I B • M, B • PW, B • C, B • PD, B • PPI, B • C • PW, B • PD • PW, B • PP • PW, B • PP • PW, B • TD • PW, B • C • M, Dx B.C. B.P1). B.TD. B.PPI. B+PD). B+E

Note 2 Includes imaging for guidance of bropsy

Note 3 includes infertifity monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrowm and penis in adult, pediation and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: JD imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indication for use

page 6 0110

{13}------------------------------------------------

510(k) No.:

Device Name: L3-12A for use with UGEO WS80A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Other (spec.)

N= new indication: P= previously cleared by FDA: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Noc 1: B+M, B+PW, B+C, B+PD, B+PPI, B+TD, B+TD, B+TD, B+D+PW, B+PP+PW, B+PP+PW, B+C+M, Dwd/Qwdd8, B+C, B+PD, B+TD, B+PPI, B+PD), B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of fallicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8. 3D imaging

Note 9 Spatial Compound Imaging

Note 10: Includes Renal. Gynecology Pelvis

Note 11 Panoramic imaging Nolc 12: ItlastoScan

NOTE 12: ADJUSTABLE

Concurrence of CDRH, Office of in I'iro Diagnostics and Radiological Ilealth (OIR) Prescription Use (Per 21 CFR 801.109)

Indication for use

page 7 of70

{14}------------------------------------------------

510(k) No.:

్రామం

Device Name: L5-13 for use with UGEO WS80A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation ("includes simultaneous B-mode)
General	Specific	H	M	PWO	CWD	Color	Combined®	Other
(Track I only)	(Tracks I & III)					Doppler®	(Spec.)	(Spec.)
Ophihalmic	Ophthalmic
	Fetal/Obstettics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pedistric
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethrai
	Trans-esoph (non-Cardiac)
	Musculo-skel. (Convers.)	P	P	P		e	Note l	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note I	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec )
	Cardiac Adull
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
Vessel	Other (spec.)

N= new indication: P= previously cleared by FDA K 130803: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note I: B+M, B+PW, B+C, B+PD, B+PPI, B+TD, B+C+PW, B+PD+PW, B+PP+PW, B+PP+PW, B+C+M, Dml/Ruddl8, B+C. B+PD. B+TD. B+PPI. B+PD). B+E

Note 2. Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of fallicle development

Note 4. Color M-mode

Note 5: For example: thyroid, parathyroid, breast, serotum and penis in adult, pediatric and neconatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Concurrence of CDRH, Office of in Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801 109)

Indication for usc

page 8 of10

{15}------------------------------------------------

510(k) No.:

ﺑ

Device Name: V4-8for use with UGEO WS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks 1 & 111)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K103397; E= added under Appendix E

Additional Comments:

Cotor Doppier includes Power (Amplitude) Doppler

Note I: B+M, B+PW, B+C, B+PD, B+PPI, B+TD, B+C+PW, B+PD+PW, B+PP+PW, B+PN+PW, B+TD+PW, B+C+M, D=a/YQuddB,

B+C, B+PD, B+TD, B+PP1, B+PD), B+E Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Nate 4: Color M-mode

Note 5: For example: thyroid, perathyroid, breast, scrown and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaying

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Concurrence of CDRH, Office of In Vitro Diagnostics and Rediological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indication for use

page 9 of10

{16}------------------------------------------------

510(k) No.:

Device Name: V5-9for use with UGEO WS80A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks 1 & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Na new indication: P= previously cleared by FDA K103397: E= added under Appendix E

Additional Comments:

Cotor Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PP, B+TD, B+C+PW, B+PD+PW, B+PP+PW, B+PP+PW, B+C+M, Dwd/QwdfB. B+C. B+PD. B+TD, B+PPI, B+PD), B+E

Note 2: Includes imaging for guidance of biopsy

Note 3. Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Concurrence of CDRH, Office of In Viro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indication for use

page 10 of10

Regulation Number and Section

§ 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.