MYLABSEVEN, MYLABALPHA

• K Number: K142008
• Device Name: MYLABSEVEN, MYLABALPHA
• Manufacturer: ESAOTE S.P.A.
• Date Cleared: 2014-09-12 ( 51 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K111302 , K132231 , K132466
• Predicate For: K153277 , K161359

Intended Use

Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatic, Small organs, Musculoskeletal (Conventional and Superlicial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, Laparoscopic and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric, Intraoperative abdominal and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Device Description

Model 6400 is a mainframe system equipped with wheels allowing to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes). 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 has been designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302, K132231 and K132466.

6400 and 7400 Upgrades, defined herein, combine the cleared features of both 6400 and 7400 systems with new capabilities, listed below:

• 1. Management of Quality Intima Media Thickness (QIMT) on both 6400 and 7400 upgrades.
• Management of Elastosonograpy qualitative analysis (ElaXto) on both 6400 and 7400 upgrades. 2.
• 3. Management of Laparoscopic application on 6400 upgrade.

The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Esaote S.p.A.'s 6400 and 7400 Ultrasound Systems. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with specific performance metrics defined by acceptance criteria and clinical studies.

Therefore, the document does not contain information about explicit acceptance criteria for a device's performance (e.g., sensitivity, specificity, accuracy thresholds) or a study specifically designed to prove the device meets such criteria in terms of diagnostic effectiveness for new functionalities.

Instead, the submission focuses on demonstrating that the new functionalities and upgrades to the existing ultrasound systems (6400 and 7400) employ the same fundamental technological characteristics as their predicate devices and that no clinical tests were performed to establish new performance metrics. The clearance is based on adherence to safety and performance standards for ultrasound devices and equivalence to previously cleared devices for various clinical applications and modes of operation.

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

1. Table of acceptance criteria and the reported device performance:

This information is not applicable in the context of this 510(k) submission for substantial equivalence. The document doesn't define specific "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for the upgraded device or report results of a study demonstrating these. The "performance" is implicitly deemed equivalent to the predicate devices and compliant with general safety standards. The document primarily focuses on listing the intended uses and modes of operation, and noting which applications are "Previously cleared by FDA" (P) or "Added under Appendix E" (E), implying that these additions are equivalent to those found in other cleared devices.

2. Sample size used for the test set and the data provenance:

No sample size for a test set is provided as no clinical tests were performed. The submission explicitly states: "No clinical tests were performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical tests requiring expert-established ground truth were performed.

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

Not applicable, as no clinical tests requiring adjudication were performed.

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 FDA submission is for a conventional ultrasound system and its upgrades, not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or reported.

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

Not applicable. This submission is for an ultrasound system, not a standalone algorithm.

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

Not applicable. Since no clinical tests were performed, there was no need to establish ground truth for a test set related to diagnostic effectiveness. The ground truth for safety and performance would relate to engineering specifications and compliance with standards.

8. The sample size for the training set:

Not applicable. The submission does not describe the development of a machine learning algorithm or AI component, thus there is no training set in the context of an AI model.

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

Not applicable. As there is no mention of a training set for an AI model, the method for establishing its ground truth is not relevant here.

---

In summary, this document is a 510(k) premarket notification for an ultrasound system upgrade, which relies on demonstrating substantial equivalence to previously cleared devices and adherence to recognized safety and performance standards, rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

September 12, 2014

Esaote S.p.A. % Ms. Allison Scott Senior Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K142008

Trade/Device Name: 6400 and 7400 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 22, 2014 Received: July 23, 2014

Dear Ms. Scott:

This letter corrects our substantially equivalent letter of September 12, 2014.

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 6400 & 7400 Ultrasound Systems, as described in your premarket notification:

Transducer Model Number- 6400

SP2430	SP2442	LA435
LA523	AL2442	AL2443
SL1543	SL2325	AC2541
SC3123	CA430	S2MCW
S5MCW	SHFCW	S2MPW
SE3123	EC1123	TRT33
ST2613	ST2612	IOT342

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IOT332	IOE323	LP323
BC431	BC441	SB2C41
BE1123	SB3123
Transducer Model Number- 7400
SP2430	SP2442	AL2442
AL2443	SL1543	SL2325
AC2541	SC3123	S2MCW
S5MCW	SHFCW	S2MPW
SE3123	EC1123	ST2613
ST2612	IOT342	SB2C41
SB3123

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 (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 Industry and Consumer Education at its toll-free 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" (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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142008

Device Name MyLabAlpha (7400), MyLabSeven (6400)

Indications for Use (Describe)

Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatic, Small organs, Musculoskeletal (Conventional and Superlicial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, Laparoscopic and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric, Intraoperative abdominal and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P		P
Fetal	P	P	P	P	P	P	P		P	P: 5, 6
Abdominal	P	P	P	P	P	P	P		P	P: 5, 6
Intraoperative (Abdominal)	P	P	P	P	P	P	P		P	P: 5
Intraoperative Neurological	P	P	P	P	P	P	P		P	P: 5
Pediatric	P	P	P	P	P	P	P		P	P: 5
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5
Neonatal Cephalic	P	P	P	P	P	P	P		P	P: 5
Adult Cephalic	P	P	P	P	P	P	P		P	P: 5
Cardiac [2]	P	P	P	P	P	P	P	P	P (7)	P: 5
Transesophageal (Cardiac) [2]	P	P	P	P	P	P	P	P	P	P: 5
Transesophageal (Non Cardiac)
Transrectal	P	P	P	P	P	P	P		P	P: 5, 6
Transvaginal	P	P	P	P	P	P	P		P	P: 5, 6
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5
Laparoscopic	N	N	N		P	N	N		N	N: 5
Musculo-skeletal Conventional		P	P			P	P			P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)	P	P	P	P	P	P	P		P	P: 5

6400
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as foll

: New indication; P: Previously cleared by FDA; E:Added under

] Small Organs includes Breast, Thyroid and Testicle
| Cardiac is Adult and Pediatric
| Musculo Skeletal - Nerve Block
| Combined modes are: B+M+PW+CW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

anc [7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification
visualization of the left ventricular endocardial border

Previously cleared via K111302,
K132231, K132466

escription Use Only Per 21 CFR 801 Part D Concurrence of CDF

Page 2 of 32

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Pres

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and

Previously cleared via K111302,
K132231, K132466

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P		P	P: 5, 6
Fetal	P	P	P	P	P	P	P		P	P: 5, 6
Abdominal	P	P	P	P	P	P	P		P	P: 5
Intraoperative (Abdominal)	P	P	P	P	P	P	P		P	P: 5
Intraoperative Neurological	P	P	P	P	P	P	P		P	P: 5
Pediatric	P	P	P	P	P	P	P		P	P: 5
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5
Neonatal Cephalic	P	P	P	P	P	P	P		P (7)	P: 5
Adult Cephalic	P	P	P	P	P	P	P		P	P: 5
Cardiac [2]	P	P	P	P	P	P	P		P	P: 5
Transesophageal (Cardiac) [2]	P	P	P	P	P	P	P		P	P: 5
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P		P	P: 5, E: 6
Transrectal	P	P	P	P	P	P	P		P	P: 5, E: 6
Transvaginal	P	P	P	P	P	P	P		P	P: 5
Transurethral	P	P	P	P	P	P	P		P	P: 5
Intravascular	P	P	P	P	P	P	P		P	P: 5
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5
Laparoscopic	P	P	P	P	P	P	P		P	P: 5
Musculo-skeletal Conventional	P	P	P	P	P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P	P: 5
Other (Urological)	P	P	P	P	P	P	P		P	P: 5

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows 7400

Page 34 of 2406

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						Body as ronovs.
Clinical Applicatio	ਸੂ	N	PWD	CWD	Color Doppler	mplitude Doppler (PD)	Combined [4]	issue Velocit) Lapping (TVM	Harmonic maging (TE)	Other (specif
Ophthalmic
Fetal	d	d	d	d			d			P: 5
Abdominal	d	d	d	d	d d	d d	d		മ്പ്	P: 5
ntraoperative (Abdomina
ntraoperative Neurologic
Pediatric	d	d	d	d	d	d	d		d	P: 5
Small Organs [1
Neonatal Cephalic Adult Cephalic	d	d	d	d	d	d	d		d	6:5
	d	d	d	d	d	d	d		d	P: 5
Cardiac [2] Transesophageal (Cardi	d	d	d	d	d	d	d	d	P (7)	സ்.
ransesophageal (Non Cardi
ransrecta
ransvagina
ransurethra
ntravascular
Peripheral Vascula	d	d	d	d	d	d	d		d	സd
aparoscopic
Musculo-skeletal Conventionજિ
Musculo-skeletal Superfici:
Other (Urologica
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P
Scrotal	P	P	P	P	P	P	P			P: 5
Abdominal	P	P	P	P	P	P	P			P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P			P: 5
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)
Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P		P	P: 5
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

SP2430 (6400 and 7400 systems)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

US Small Organs includes Breast, Thyroid, etc.

[2] Cardiac is Adult and Pediatric

3. Musculo Skeletal - Nerve Block

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and
visualization of the left ventricular endocardial border

Previously cleared via K132466

Page 35 of 2406

Page 4 of 32

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escription Use Only Per 21 CFR 801 Part D Concurrence of CDRR

SP2442 (6400 and 7400 systems)
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

M
E
N
U

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD

2. Cardiac is Adult and Pediatric :

[3] Musculo Skeletal - Nerve Block

[4] Combined models are D.M. DIV. CPU

[5] Compound Imaging (Mview)

Previously cleared via k13223

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escription Use Only Per 21 CFR 801 Part D Concurrence of CDRR

LA435 (6400 systems)
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

App ру

CT Similar Organs Includes Breast, Thyroid and etc.

2. Cardiac is Adult and Pediatric

[32] Musculo Skeletal - Nerve Block

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[5] Compound Imaging (Mview)

Previously cleared via K14067

Page 6 of 32

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LA523 (6400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previously cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

A) Combined modes are: B+M; B+M+PW; B+M+PW+CFN

[5] Compound Imaging (Mview)

reviously cleared via K14067

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRF

Page 7 of 32

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age 39 of 2406

Page 8 of 32

ription Use Only Per 21 CFR 801 Part D Concurrence of

Intraoperative Neurological
Pediatric	P	P	P	P	P	P
Small Organs [1]	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

P: 5

P: 5

P: 5

.2442 (6400 and 7400 systems)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Deather

Other (specify)

Harmonic
Imaging (TEI)

Tissue Velocity
Mapping (TVM)

Amplitude | Combined | Doppler

Color
Doppler

CWD

PWD

M

в

Clinical Application

Ophthalmic

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ntraoperative (Abdominal

Abdominal Fetal

ം: 5 P: 5 P: 5

Small Organs includes Breast, Thyroid and Testicle
Cardiac is Adult and Pediatric
Musculo Skeletal - Nerve Block
Combined modes are: B+M+PW+CFM+PD

[3]
[4]
Musculo Skeletal - Nerve Block
Combined modes are: B+M+RW+CE

[4] Combined modes are: B+M+PW+CFM+F

Compound Imaging (Mviev

eviously cleared via k1414

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

Page 9 of 32

Pr

Research Use Only. Part D Contains: COOH
21 CFR 801 Part D Contains: COOH

Previously cleared via K132466

[5] Compound Imaging (Mview)

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P		P	P: 5
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	E	E	E		E	E	E		E	E: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)

AL2443 (6400 and 7400 systems)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body

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

rescription Use Only Per 21 CFR 801 Part D Concurrence of CDRR

		Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)
Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	E	E	E		E	E	E		E	E: 5
Small Organs [1]	E	E	E		E	E	E		E	E: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	E		E		E	E	E		E	E: 5
Laparoscopic
Musculo-skeletal Conventional	E	E	E		E	E	E		E	E: 5
Musculo-skeletal Superficial [3]	E	E	E		E	E	E		E	E: 5
Other (Urological)
New indication: P: Previously cleared by FDA; E: Added under Appendix E
cended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P			P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)	P	P	P		P	P	P		P	P: 5
I: New indication; P: Previously cleared by FDA; E:Added under Appendix E
SC3123 (6400 and 7400 systems)Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
						Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other
Ophthalmic
Fetal	E	E	E		E	E	E		E
Abdominal	E	E	E		E	E	E		E
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	E	E	E		E	E	E		E
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	E	E	E		E		E		E
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	E	E	E		E	E	E		E
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	E	E	E
Fetal	E	E	E
Abdominal					E	E	E		E	E: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					E	E	E		E	E: 5
Laparoscopic
Musculo-skeletal Conventional[3]			E		E	E	E		E	E: 5
Musculo-skeletal Superficial [3]			E		E	E	E		E	E: 5
Other (Urological)			E		E	E	E		E	E: 5

SL1543 (6400 and 7400 systems)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as foll

rbb "S y FDF

[1] Small Organs Includes Breast, Thyroid and etc.

2. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[5] Compound Imaging (Mview)

Previously cleared via k14148

Page 10 of 32

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

Page 11 of 32

Page 42 of 2406

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRF

SL2325 (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

2] Cardiac is Adult and Pediatric

[4] Combined modes are: B+M+PW+
+CEM+P-

[5] Compound Imaging (Mview)

To be cleared with this
submission

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

Page 43 of 2406

Page 12 of 32

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRF

ાંત્વે માત AC2541 (6400 and 7400 systems)

ntended use: Diagnostic ultrasound imaging or flu

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

(2) Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview

reviously cleared via K141486

usly cleared via K141486

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

Page 13 of 32

scription Use Only Per 21 CFR 801 Part D Concurrence of CDR

E: 5

Other (specify)

E: 5

E: 5

Thyroid and Testicles

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[4] Combined modes are: B+M+PW+CFM+P

[5] Compound Imaging (Mview)

Previously cleared via K141486

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

Page 45 of 2406

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

CA430 (6400 system)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Source: U.S. Census Bureau, Current Population Survey, Annual Social and Economic Supplements.

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[5] Compound Imaging (Mview)

Previously cleared via k13390

Page 14 of 32

{17}------------------------------------------------

Page 15 of 32

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRR

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are:

[5] Compound Imaging (Mview)

Previously cleared via K141486

						Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]				P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)

S2MCW (6400 and 7400 systems)

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

{18}------------------------------------------------

Pre

Source: Concurrent DisordersProgram, 221 Concession St.Hamilton, ON L8V 1C6
FR800 per 21 concurrentepisodes of CD

Medical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]				P
Musculo-skeletal Superficial [3]
Other (Urological)

S5MCW (6400 and 7400 systems

Only Part 2, Der. 2, 1980CFE Research Application.

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are:

[5] Compound Imaging (Mview)

reviously cleared via K141486

Page 16 of 32

{19}------------------------------------------------

Page 17 of 32

Page 48 of 2406

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRF

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are:

[5] Compound Imaging (Mview)

Previously cleared via K141486

SHFCW (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human b

{20}------------------------------------------------

Page 49 of 2406

escription Use Only Per 21 CFR 801 Part D Concurrence of CDR

		9

reviously cleared via k1324

[5] Compound Imaging (Mview)

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic			P
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
New indication: P: Previously cleared by FDA; E:Added under Appendix E

S2MPW (6400 and 7400 systems)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

{21}------------------------------------------------

Page 19 of 32

Pre

I
2R
CDI
>€
ce4œ
D
MMAN.
1ان
€4
)0
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D0
t
al
D
1
80
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LI
CD
21
Sel
10
C1
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0A)
ﺎﺭ
MIATIA1
1
54
CSCC

Previously cleared via K141486

[5] Compound Imaging (Mview)

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P		P	P: 5
Transvaginal	P	P	P		P	P	P		P	P: 5
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional[3]
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P. 5
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	P
Fetal		P	P		P	P	P
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal		P	P		P	P	P		P	P: 5
Transvaginal		P	P		P	P	P		P	P: 5
Transurethral			P
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional			P			P	P
Musculo-skeletal Superficial [3]			P			P	P
Other (Urological)		P	P		P	P	P		P	P: 5

SE3123 (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow

{22}------------------------------------------------

Page 51 of 2406

rescription Use Only Per 21 CFR 801 Part D Concurrence of CDRK

EC1123 (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Previously cleared via K14067

P: Prior notification; P: Previously cleared by FDA; E:

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[2] Cardiac is Adult and Pediatric

[4] cut due to hurt with Pneumatic
[3] Musculo Skeletal - Nerve Block

[3] Musculo Skeletal - Nerve Block

[5] Compound Imaging (Mview)

{23}------------------------------------------------

Page 21 of 32

rescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Previously cleared via K133905

[5] Compound Imaging (Mview)

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

ntended use. Diagnostic ultrasound imaging of fiuld now analysis of numan body as Ollows.
Clinical Applicatio	ਸਿ	M	PWD	CWD	Color Doppler	mplitude Doppler Doppler (PD)	Combined Combined [4]	issue Velocity Iapping (TVM)	Harmonic maging (TE	Other (specify)
Ophthalmic
Fetal
bdominal
ntraoperative (Abdomina
ntraoperative Neurologic
Pediatric
Small Organs [1
Teonatal Cephalic
dult Cephalic
Cardiac [2]
ransesophageal (Cardia
ransesophageal (Non Cardia
ransrecta					d	d	d		d	P: 5
ransvagina
ransurethra
ntravascular
Peripheral Vascula
laparoscopic
Musculo-skeletal Conventionજિ
Musculo-skeletal Superficia
Other (Urological		d								സੱਕ
N: New indication; P: Previously cleared by FDA; E:Added under Appendix
Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)	E	E	E	E	E	E	E	E	E	E, 5
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	Mode of Operations
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)							P
Intraoperative Neurological								P
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]		P	P	P	P	P
Transesophageal (Cardiac)									P
Transesophageal (Non Cardiac)										P: 5
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)

TRT33 (6400 system)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

{24}------------------------------------------------

Page 22 of 32

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRF

CONFIDENTIAL

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview

To be cleared with this submission

ST2613 (6400 and 7400 systems)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

{25}------------------------------------------------

Page 23 of 32

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRR

ST2612 (6400 and 7400 systems)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human

ಎಂ

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD

[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block

[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CE

[4] Combined modes are: B+M+PW+CW+CFM+

[5] Compound Imaging (Mview)

Previously cleared via K141486

{26}------------------------------------------------

Page 55 of 2406

Page 24 of 32

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRF

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Total
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)	P	P	P		P	P	P		P	P: 5
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)

IOT342 (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

2. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+PD

[5] Compound Imaging (Mview)

Previously cleared via K141486

{27}------------------------------------------------

escription Use Only Per 21 CFR 801 Part D Concurrence of CDR

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)	P	P	P		P	P	P		P	P: 5
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)
P: New indication; P: Previously cleared by FDA; E:Added under Appendix E

ain a in IOT332 (6400 system)

htended use: Diagnostic ultras

N: New indication; P: Previously cleared by FDA; E:Added under Apper

1. Small Organs includes Breast, Thyroid and etc.

2. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[5] Compound Imaging (Mview)

reviously cleared via k13390

Page 25 of 32

{28}------------------------------------------------

Page 57 of 2406

Page 26 of 32

ription Use Only Per 21 CFR 801 Part D Concurrence of

Small Organs [1]	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E[1] Small Organs includes Breast, Thyroid and Testicles

P: 5

P: 5

P: 5

0E323 (6400 system)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human

Other (specify)

Harmonic
Imaging (TEI)

Tissue Velocity
Mapping (TVM)

Amplitude | Combined | Doppler

Color
Doppler

CWD

PWD

M

в

Clinical Application

Ophthalmic

ਤੇ ਹੋ
ਤੇ ਜ

d ﮩﻢ ﮨﮯ

d

в P

d P

d P

പ്പിച്ചു. പുറ്റുക

d P ﮨﮯ d

Intraoperative (Abdominal)
Intraoperative Neurologica

Pediatric

Abdominal

Fetal

P: 5 P: 5

d d

d d

P d

ﮨﮯ പ

d d

P d

[1] Small

2. Cardiac is Human and Pediatric
3. Musculo Skeletal - Nerve Block

Cardian organo morado endration inspectation
Cardiac is Adult and Pediator
Musculo Skelettal - Nerve Block
Combined modes are: B+M+PW+CFM+PDF

1. COMBINED MODES ARE AC, BD, AE, BF, CM, DM, EM, FM, CN, DN, EN, FN

Compound Imaging (Mviev

eviously cleared via K1406

via K140677

{29}------------------------------------------------

LP323 (6400 system)

Intended use: Diagnostic ultras

Intended use: Diagnostic	ultrasound imaging or fluid flow analysis of human body as follows:
						Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P			P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic	P	P	P		P	P	P			P: 5
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]									P
Other (Urological)

and ima

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

MINIMUM CONTENT AND FORMATTING REQUIREMENTS FOR ALL SUBMISSIONS

[See the Submission Guidelines for more details.]

3. Musculo Skeletal - Nerve Blood

[4] Combined modes are: B+M+PW+CFM+F

[5] Compound Imaging (Mview)

Previously cleared via K140677

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 58 of 2406

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escription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P			P: 5, 6
Abdominal	P	P	P		P	P	P		P	P: 5, 6
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	Mode of Operations							Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5, 6
Abdominal	P	P	P		P	P	P		P	P: 5, 6
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]

BC431 (6400 system

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

2. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+F

[5] Compound Imaging (Mview)

[6] 3D/4D

Previously cleared via K133905

{31}------------------------------------------------

BC441 (6400 system)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

T

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

p. 106

ERC Naming Scheme - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview)

D
D

[6] 3D/4D

Previously cleared via K133905

rescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

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cription Use Only Per 21 CFR 801 Part D Concurrence of C

	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]
	P	P	P	P	P	P	P
	P	P	P	P	P	P	P

Intraoperative (Abdominal)
Intraoperative Neurological

Abdominal

Transesophageal (Cardiac)
Transesophageal (Non Cardiac)

Neonatal Cephalic
Adult Cephalic

Cardiac [2]

Small Organs [1]

Pediatric

0 SB2C41 (6400 AND

htended use: Diagnostic ultra

ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as fo

Clinical Application

Ophthalmic

Fetal

Other (specify)

Harmonic
Imaging (TEI)

Tissue Velocity
Mapping (TVM)

P: 5, 6 P: 5, 6

d d

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

N: New indication; P: Previously cleared by FDA; E:Added under Appendix

Musculo-skeletal Superficial [3]

31

Other (Urological)

Laparoscopic
Musculo-skeletal Conventional

Peripheral Vascular

ransurethral Intravascular

Transrectal
Transvaginal

2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+E

[5] Compound Imaging (Mview

[6] 3D/4D

eviously cleared via k14148

{33}------------------------------------------------

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escription Use Only Per 21 CFR 801 Part D Concurrence of CDRR

Arotec SpA 6400-7400 barade 510(k)
saote.

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P
Fetal		P	P		P	P	P		P	P: 5, 6
Abdominal	P	P	P		P	P	P		P	P: 5, 6
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	E	E	E		E	E	E		E	E, 5, 6
Fetal	E	E	E		E	E	E		E	E, 5, 6
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	E	E	E				E			E: 5, 6
Transvaginal	E	E	E		E	E	E		E	E: 5, 6
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

BE1123 (6400 system)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

PENNSYLVANIA STATE UNIVERSITY
GRADUATE SCHOOL

APPLICATION FOR DEGREE
(For Graduate School Use Only)

Date Received:

Date Approved:

Degree:

Major:

Option:

Minor:

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

2. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+F

[5] Compound Imaging (Mview)

[6] 3D/4D

Previously cleared via K133905

{34}------------------------------------------------

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escription Use Only Per 21 CFR 801 Part D Concurrence of CDR

SB3123 (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

NOT VALID FOR
REIMBURSEMENT
INFORMATION ONLY
NOT VALID FOR
REIMBURSEMENT
INFORMATION ONLY
NOT VALID FOR
REIMBURSEMENT
INFORMATION ONLY
NOT VALID FOR
REIMBURSEMENT
INFORMATION ONLY

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

(2) Cardiac is Adult and Pediatric

MSK (Musculo Skeletal) - Nerve Block

[5] Compound Imaging (Mview)

[6] 3D/4D

Previously cleared via k13223

{35}------------------------------------------------

510(k) Submission 6400 and 7400 Upgrade Esaote, S.p.A.

Traditional 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.

807.92(a)(1)

Submitter Information

Esaote S.p.A. Via di Caciolle 15 Firenze, Italy 50127

Allison Scott Contact Person: 317.228.8719 [e-mail]

July 22, 2014 Date:

807.92(a)(2)

Devices

Common Name:	Ultrasound Imaging System
Trade Name:	6400 Ultrasound System7400 Ultrasound System
Classification Name(s):	Ultrasound Pulse Doppler Imaging System 892.1550Ultrasound Pulse Echo Imaging System 892.1560Transducer, Ultrasonic, Diagnostic 892.1570
Classification Number:	90IYN, 90IYO, 90ITX

807.92(a)(3)

Predicate Device(s)
Device	Owner	510(k)
6400	Esaote	K111302, K132231,K132466
7400	Esaote
7340	Esaote	K081794, K091009,K110688

{36}------------------------------------------------

Device	Owner	510(k)
6150	Esaote	K051308, K052805,K060827, K081386,K091009

807.92(a)(4)

Device Description

Model 6400 is a mainframe system equipped with wheels allowing to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes). 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 has been designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302, K132231 and K132466.

6400 and 7400 Upgrades, defined herein, combine the cleared features of both 6400 and 7400 systems with new capabilities, listed below:

• 1. Management of Quality Intima Media Thickness (QIMT) on both 6400 and 7400 upgrades.
• Management of Elastosonograpy qualitative analysis (ElaXto) on both 6400 and 7400 upgrades. 2.
• 3. Management of Laparoscopic application on 6400 upgrade.

The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use

Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, Laparoscopic and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

{37}------------------------------------------------

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

807.92(a)(6)

Technological Characteristics

The 6400 and 7400 Upgrades employ the same fundamental technological characteristics as their predicate devices.

The 6400 Upgrade model is substantially equivalent to Esaote 6150 model cleared via K051308, K052805, K060827, K081386, K091009 and to Esaote 6400 model cleared by FDA via K111032, K13231, K132466.

The 7400 Upgrade model is substantially equivalent to Esaote 7340 model cleared via K081794, K091009, K110688 and to Esaote 7400 model cleared by FDA via K111032, K132231, K132466.

• Clinical uses for which Esaote 6400 and 7400 models have been cleared by FDA via K111032, K132231, K132466 are not changed by 6400 and 7400 Upgrades, to be cleared via this submission.
• Clinical uses for which Esaote 6400 and 7400 Upgrades are designed are equivalent to those of Esaote 6150 model, cleared via K051308, K052805, K060827, K081386, K091009, and of Esaote 7340 model, cleared via K081794, K091009, K110688.
• 6400 Upgrade and 7400 upgrade for managing Quality Intima Media Thickness (QIMT) are equivalent to those of Esaote 6150 model, cleared via cleared via K051308, K052805, K060827, K081386, K091009, and of Esaote 7340 model, cleared via K081794, K091009, K110688.
• 6400 Upgrade and 7400 Upgrade for managing Elastosonography qualitative analysis are equivalent to those of Esaote 6150 model, cleared via cleared via K051308, K052805, K060827, K081386, K091009, and of Esaote 7340 model, cleared via K081794, K091009, K110688.
• 6400 Upgrade for managing Laparoscopic application is equivalent to those of Esaote 6150 model, cleared via K051308, K052805, K060827, K081386, K091009.
• Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400, 6150 and 7340 are designed to meet the IEC60601-1.
• · Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400, 6150 and 7340 are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
• Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400, 6150 and 7340 ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.

{38}------------------------------------------------

510(k) Submission 6400 and 7400 Upgrade Esaote, S.p.A.

807.92(b)(1)

Summary of Non-Clinical Tests

The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.

• IEC 60601-1
• IEC 60601-1-2 ●
• IEC 6060 1-2-37
• NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• . NEMA UD-2 - Acoustic Output Measurement Standard for Diagnostic Ultrasound

807.92(b)(2)

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusion

The 6400 and 7400 Upgrades are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

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.