Esaote's MyLabOne is an arm-held ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Obstetrics/Gynaecology, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urology. The system provides imaging for guidance of biopsy and imaging to assist in t the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Device Description

The MyLabOne is a battery operated, portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Color Flow Mapping (CFM) and Pulse Wave Doppler.

The MyLabOne is equipped with a LCD Color Display. The LCD Display includes touch screen technology for a simple and intuitive activation of functions and data entry for patient information and screen annotations.

The MyLabOne can drive phased (PA), convex (CA) and linear array (LA) probes. The MyLabOne is equipped with an internal Hard Disk and with an optional external DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the MyLabOne include a monochrome or color page printer, a desk stand (for use on a desk or cart) and a mobile trolley equipped with four swiveling wheels and peripheral holder.

AI/ML Overview

The provided document is a 510(k) summary for the Esaote MyLabOne Ultrasound System, seeking clearance for a new ultrasound device. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended uses and technical characteristics of the new system and its associated transducers.

Crucially, the document does not contain information about acceptance criteria for device performance, nor does it describe a specific study proving the device meets particular acceptance criteria in terms of diagnostic accuracy or clinical effectiveness.

Instead, the submission relies on the concept of substantial equivalence to predicate devices (K083882 MyLabFive and K092058 NanoMaxx). The "studies" mentioned are non-clinical verification and validation tests conducted in accordance with design controls per CFR 820.30, and compliance with various international standards related to safety and acoustic output.

Therefore, many of the requested details cannot be extracted directly from this document. However, based on the information provided, here's what can be inferred or explicitly stated:

Acceptance Criteria and Device Performance

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are primarily that the new device (MyLabOne) and its transducers perform comparably to the predicate devices in terms of image modes, safety, acoustic output, and measurement capabilities.

There is no table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes because such studies are generally not required for 510(k) clearances that rely on substantial equivalence for ultrasound imaging systems unless new claims or significant technological differences are introduced.

The document states:

"The MyLabOne image modes are available on other FDA cleared ultrasound systems. for instance the Esaote MyLabFive and Sonosite NanoMaxx."
"The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx provide a similar measurements and analysis package, with equal accuracy and precision."
"The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx are designed to meet the IEC60601-1 and the IEC60601-2-37 safety requirements."
"The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values."

This implies that the performance is accepted if it adheres to the capabilities, safety standards, and acoustic output levels of the legally marketed predicate devices.

Specific Requested Information:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferred from Substantial Equivalence):
  - Clinical uses similar to predicate devices.
  - Compliance with safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37).
  - Compliance with biocompatibility standards (ISO 10993-1 for transducers if applicable, though not specified for device itself).
  - Acoustic output display feature per AIUM/NEMA standards.
  - Equivalent maximal Ispta and MI values to predicate devices.
  - Similar measurement and analysis package with equal accuracy and precision to predicate devices.
  - Equivalent image modes to predicate devices.
- Reported Device Performance: The document generally states that the MyLabOne is substantially equivalent and provides these features and compliance. Specific quantitative performance metrics (e.g., image resolution, diagnostic accuracy rates) are not provided in this 510(k) summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided for clinical performance. The document does not describe a clinical "test set" in the context of diagnostic accuracy or effectiveness studies. "Verification and validation tests" were done in accordance with design controls, which typically involve engineering and performance testing, not clinical data sets for diagnostic accuracy.
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):
- Not Applicable / Not Provided. As no clinical test set for diagnostic performance is described, there's no mention of experts establishing ground truth for such a set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided.
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:
- No. This document describes a general-purpose ultrasound imaging system. It is not an AI-powered diagnostic device, and therefore, no MRMC study or AI assistance evaluation is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is an ultrasound imaging system, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided for clinical diagnostic use. For engineering verification and validation, ground truth would refer to reference standards, phantoms, or simulated signals for technical performance parameters (e.g., acoustic output, measurement accuracy), but these details are not elaborated in the summary.
The sample size for the training set:
- Not Applicable / Not Provided. This is not an AI/ML device that requires a training set in the conventional sense.
How the ground truth for the training set was established:
- Not Applicable / Not Provided.

In summary: The K101605 510(k) submission for the MyLabOne Ultrasound System relies on demonstrating substantial equivalence to previously cleared predicate devices by confirming similar intended uses, technological characteristics, and compliance with relevant safety and performance standards. It does not include primary clinical studies with specific diagnostic performance metrics, test sets, or ground truth establishment by experts, as these are typically not required for this type of submission for a general ultrasound imaging system.

Summary

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K101605

AUG 31 2010

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).

807.92(a)(1)

Submitter Information

Esaote Europe B.V. Philipsweg 1 Maastricht 6227AJ The Netherlands

Contact Person:

Allison Scott, RAC 317.569.9500 x106 ascott@ansongroup.com

Date:

March 22, 2010

807.92(a)(2)

Trade Name:

MyLabOne Ultrasound System

Common Name:

Ultrasound Imaging System

Classification Name

e(s):	Ultrasonic pulse Doppler imaging system	892.1550
	Ultrasonic pulsed echo imaging system	892.1560
	Diagnostic ultrasonic transducer	892.1570

Classification Number:

90IYN, 90IYO, 90ITX

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

807.92(a)(3)

Predicate Device(s)

K083882	MyLabFive	Esaote Europe B.V.
K092058	NanoMaxx	SonoSite, Inc.

Additional substantial equivalence information is provided in the following substantial equivalence comparison table.

807.92 (a)(4)

Device Description

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807.92(a)(5)

Intended Use(s)

807.92(a)(6)

Technological Characteristics

Esaote believes that the MyLabOne is substantial equivalent to Esaote's MyLabFive product (K083882) and SonoSite's Nanomaxx product (K092058).

· Clinical uses for which the MyLabOne is designed are equivalent to those cleared for the Esaote MyLabFive and the SonoSite NanoMaxx.
· The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx are designed to meet the IEC60601-1 and the IEC60601-2-37 safety requirements.
· The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
· The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx provide a similar measurements and analysis package, with equal accuracy and precision.
· The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx have digital storage capabilities, including Network connectivity.
· The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx are designed to be powered by battery when no main power is available.
· The MyLabOne image modes are available on other FDA cleared ultrasound systems. for instance the Esaote MyLabFive and Sonosite NanoMaxx.

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

807.92(b)(1)

Non-Clinical Testing

Verification and validation tests have been conducted in accordance with design controls per CFR 820.30.

The system has been designed to meet the following standards:

. IEC 60601-I
IEC 60601-1-2 .
IEC 60601-2-37 .
ISO 10993-1 .
AIUM/NEMA UD-3 Standard for Real Time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound .

. .. .. . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Esaote Europe B.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313

2010 3 1

Re: K101605

Trade/Device Name: MyLabOne Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 18, 2010 Received: August 19, 2010

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the MyLabOne, as described in your premarket notification:

Transducer Model Number

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours.

signature

Jonald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known): |<{ 0(lof(005

Device Name: MyLabOne

Indications for Use:

The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

D.m.d. JHL

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101605

MyLabOne Response to FDA Deficiencies

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MyLabOne

		Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal/Obstetrics/Oyn	N	N	N	N	N	N	N		N	4
Abdominal	N	N	N	N	N	N	N		N	4
Intraoperative (Abdominal)	N	N	N	N	N	N	N		N	4
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N		N	4
Small Organ [1]	N	N	N	N	N	N	N		N	4
Neonatal Cephalic	N	N	N	N	N	N	N		N	4
Adult Cephalic	N	N	N	N	N	N	N		N	4
Cardiac [2]	N	N	N	N	N	N	N		N	4
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	N	N	N	N	N	N	N		N	4
Transvaginal	N	N	N	N	N	N	N		N	4
Transurethral
Intravascular
Peripheral Vascular (includingvascular access)	N	N	N	N	N	N	N		N	4
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	N	N	N	N	N	N	N		N	4
Musculo-skeletal Superficial(including Nerve Blocking)	N	N	N	N	N	N	N		N	4
Other (Urological)	N	N	N	N	N	N	N		N	4

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

(1) Small Organs includes Breast, Thyroid and Testicles (2) Cardiac is Adult and Pediatric
[3] Combined modes are: B + M + PW + CFM + PD
- XVicw

િનો

Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K101605

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SL3323

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal/Obstetrics/Gyn
Abdominal	N	N	N	N	N	N	N	4
Intraoperative (Abdominal)	N	N	N	N	N	N	N	4
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N	4
Small Organ [1]	N	N	N	N	N	N	N	4
Neonatal Cephalic	N	N	N	N	N	N	N	4
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular (includingvascular access)	N	N	N	N	N	N	N	4
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	N	N	N	N	N	N	N	4
Musculo-skeletal Superficial(including Nerve Blocking)	N	N	N	N	N	N	N	4
Other (Urological)

The SL3323 probe is to be cleared via

this submssion

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

(1) Small Organs includes Breast, Thyroid and Testicles [기 Cardiac is Adult and Pediatric [3] Combined modes are: B + M + PW + CFM + PD (4) XView
Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

ﯿ

(Division Sign-Off)

(Division of Radiological Devices Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Collice of In Vitro Diagnostic Device Evaluation and Safety

K101605
510K.

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SL3116

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal / Obstetrics / Gyn
Abdominal
Intraoperative (Abdominal)	N	N	N		N	N	N		N	4
Intraoperative Neurological
Pediatric	N	N	N		N	N	N		N	4
Small Organ [1]	N	N	N		N	N	N		N	4
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular (includingvascular access)	N	N	N		N	N	N		N	4
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	N	N	N		N	N	N		N	4
Musculo-skeletal Superficial(including Nerve Blocking)	N	N	N		N	N	N		N	4
Other (Urological)

The SL3116 probe is to be cleared via

this submssion

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

[1] [2]
(3)

[4]

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CFM + PD XView

Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

(Division Sign-Off) Division of Radiological De Office of In ce Evaluation and Safety

510K K101605

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SC3121

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined [3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal/Obstetrics/Gyn	N	N	N		N	N	N		N	4
Abdominal	N	N	N		N	N	N		N	4
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N		N	N	N		N	4
Small Organ [1]
Neonatal Cephalic	N	N	N		N	N	N		N	4
Adult Cephalic
Cardiac [2]	N	N	N		N	N	N		N	4
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular (includingvascular access)	N	N	N		N	N	N		N	4
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	N	N	N		N	N	N		N	4
Musculo-skeletal Superficial(including Nerve Blocking)	N	N	N		N	N	N		N	4
Other (Urological)	N	N	N		N	N	N		N	4

The SC3121 probe is to be cleared via

this submssion

Nenew indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

(1) Small Organs includes Breast, Thyroid and Testicles (기 Cardiac is Adult and Pediatric (ર) Combined modes are: B + M + PW + CFM + PD
XView
|4)
Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K.K101665

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SC3123

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal/Obstetrics/Gyn
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N		N	4
Small Organ [1]	N	N	N	N	N	N	N		N	4
Neonatal Cephalic	N	N	N	N	N	N	N		N	4
Adult Cephalic
Cardiac [2]	N	N	N	N	N	N	N		N	4
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular (includingvascular access)	N	N	N	N	N	N	N		N	4
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	N	N	N	N	N	N	N		N	4
Musculo-skeletal Superficial(including Nerve Blocking)	N	N	N	N	N	N	N		N	4
Other (Urological)

The SC3123 probe is to be cleared via

this submssion

[1]

[기

(3)

(ব)

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

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CFM + PD XView
Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH. Office of In Vitro Diagnostics Devices (OIVD)

S.D.R.

(Division Sign-Off)
Division of Radiological Devices Office of in Vitro Diagnostic Devices
Office of in Vitro Diagnostic Device Evaluation and Safety

510K Ki6605

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SC3421

		Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal/Obstetrics/Gyn	N	N	N		N	N	N		N	4
Abdominal	N	N	N		N	N	N		N	4
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N		N	N	N		N	4
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular (includingvascular access)	N	N	N		N	N	N		N	4
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	N	N	N		N	N	N		N	4
Musculo-skeletal Superficial(including Nerve Blocking)	N	N	N		N	N	N		N	4
Other (Urological)	N	N	N		N	N	N		N	4

The SC3421 probe is to be cleared via

this submasion

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

(1) Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric (2) (3) Combined modes are: B + M + PW + CFM + PD (4) XVicw
Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

(Drision Sign-Off) (Simsion of Radiological Devices Office of the Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K16605

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

SE3123

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal/Obstetrics/Gyn	N	N	N	N	N	N	N		N	4
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	N	N	N	N	N	N	N		N	4
Transvaginal	N	N	N	N	N	N	N		N	4
Transurethral
Intravascular
Peripheral Vascular (includingvascular access)
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)	N	N	N	N	N	N	N		N	4

The SE3123 probe is to be cleared via

this submssion

Nenew indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

(1) Small Organs includes Breast, Thyroid and Testicles (2) Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CFM + PD ' [4] XVicw
Prescription Use Only (Per 21 CFR 801 Part D) Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

Signature

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K116605

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.