Esaote's Model 7348 is a portable ultrasound system used to perform diagnostic general ultrasound studies including Cardiac (adult and pediatric), Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7348 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

The 7340 is a compact ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes. The 7340 system has been cleared by FDA via K081794, K091009 and K110688. The 7340 has been modified from the previously cleared version, in order to add a lowcost configuration, named 7348 (modified 7340). Advanced features (such as Stress, Strain, 3D/4D) are not available in the 7348. The main changes to model 7340 consist of the following: New plastic housing of the system to give a new style. New keyboard (control panel) where the modality to select software keys has been modified and some control keys have been replaced by software keys. New Keyboard PCB lay out to match the new organization of the panel keys. New Processor PCB group to have two configurations: basic-performance group for 7348 and high-performance group for 7340. Software modifications to translate new organization of the panel keys and to manage the two Processor PCB group configurations: all other software characteristics and performances have not been changed. The 7348 is equipped with a sub-set of the 7340 probes: the intended use of the probes remains unchanged as previously cleared. These modifications do not affect the intended use or alter the fundamental scientific technology of the 7340 system cleared via K081794, K091009 and K110688.

AI/ML Overview

The provided text is a 510(k) summary for the Esaote 7348 System, which is an ultrasound imaging system. The submission describes modifications to a previously cleared device (Esaote 7340 system) rather than a novel AI system. Therefore, many of the requested details, such as sample sizes for training/test sets, expert qualifications, and specific performance metrics for AI algorithms, are not applicable to this type of regulatory submission.

The document focuses on demonstrating substantial equivalence to predicate devices for its intended use and technological characteristics. The performance is assessed through its previously cleared versions.

Here's an attempt to answer the questions based on the provided text, acknowledging the limitations for an AI-specific evaluation:

1. A table of acceptance criteria and the reported device performance

Since this is a modification of an existing ultrasound system, the "acceptance criteria" are implicitly that the modified device (7348) maintains the same performance and intended use as the previously cleared predicate device (7340, cleared via K081794, K091009, and K110688). The device performance is deemed equivalent to the predicate.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Maintain intended use as predicate	Intended use remains unchanged (e.g., Cardiac, Peripheral Vascular, Abdominal, Fetal, etc.).
Maintain fundamental scientific technology	Fundamental scientific technology not altered.
Maintain established performance characteristics	No changes to software characteristics and performances impacting clinical utility.

The document extensively lists the clinical applications and modes of operation ("P" for "Previously cleared by FDA") for the various transducers associated with the 7348 system. This signifies that for each indicated application and mode, the performance is considered equivalent to the predicate. For example, for the 7348 system (overall), "Cardiac (adult and pediatric)" is listed with "P" across all modes (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined, TVM, TEI), indicating its performance in these areas is already cleared and accepted.

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

This information is not applicable or provided in the 510(k) summary. This submission is for a modification of an existing device, and it relies on the substantial equivalence of its technological characteristics to previously cleared predicate devices. Performance data from new clinical studies (test sets) are not typically required or presented for such modifications unless there's a significant change in intended use or technological principle.

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)

This information is not applicable or provided. Since no new clinical test sets are described, there is no mention of experts establishing ground truth for such sets. The "ground truth" here is the established safety and effectiveness of the predicate device, accepted by the FDA.

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

This information is not applicable or provided. No new clinical test sets, and therefore no adjudication methods for them, are described.

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

This information is not applicable. The device is an ultrasound system, not an AI-powered diagnostic tool requiring MRMC studies to evaluate AI assistance.

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

This information is not applicable. The device is an ultrasound system, not a standalone algorithm.

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

The "ground truth" implicitly relies on the established clinical utility and safety of the predicate ultrasound device (Esaote 7340) as accepted by the FDA through previous 510(k) clearances (K081794, K091009 and K110688). This means the prior clearances demonstrated clinical performance generally accepted in the medical community for diagnostic ultrasound.

8. The sample size for the training set

This information is not applicable or provided. The device is an ultrasound system with hardware and software modifications, not an AI algorithm trained on a dataset.

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

This information is not applicable or provided. As above, this is a hardware/software modification, not an AI system that undergoes "training" in the context of machine learning.

Summary

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

1-121384

MAY 2 3 2012

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

Contact Person:

Allison Scott 317.569.9500 x106 ascott@ansongroup.com

Date:

May 4, 2012

807.92(a)(2)

Trade Name: 7348 System

Common Name:

Ultrasonic pulse Doppler imaging system 892.1550

Classification Name(s):

Classification Number:

90IYN; 90IYO

807.92(a)(3)

Predicate Device(s)

Ultrasound Imaging System

Ultrasonic pulsed echo imaging system 892.1560

K081794, K091009. k 1 10688

7340

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

807.92 (a)(4)

Device Description

The 7340 system has been cleared by FDA via K081794, K091009 and K110688.

The 7340 has been modified from the previously cleared version, in order to add a lowcost configuration, named 7348 (modified 7340). Advanced features (such as Stress, Strain, 3D/4D) are not available in the 7348.

The main changes to model 7340 consist of the following:

New plastic housing of the system to give a new style. a.
b. New keyboard (control panel) where the modality to select software keys has been modified and some control keys have been replaced bv software keys.
c. New Keyboard PCB lay out to match the new organization of the panel kevs.
New Processor PCB group to have two configurations: basic-performance d. group for 7348 and high-performance group for 7340.
Software modifications to translate new organization of the panel keys and e. to manage the two Processor PCB group configurations: all other software characteristics and performances have not been changed.

The 7348 is equipped with a sub-set of the 7340 probes: the intended use of the probes remains unchanged as previously cleared.

These modifications do not affect the intended use or alter the fundamental scientific technology of the 7340 system cleared via K081794, K091009 and K110688.

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

807.92(a)(5)

Intended Use(s)

807.92(a)(6)

Technological Characteristics

The 7340 has been modified from the previously cleared version, in order to add a lowcost configuration, named 7348 (modifications have altered neither the fundamental scientific technology nor the intended use of the unmodified version of the 7340 cleared via K081794, K091009 and K110688.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three curved lines forming the body and head.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Esaote, S.p.A. % Allison Scott, RAC Regulatory Associate Anson Group 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K121384

Trade/Device Name: 7348 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Regulatory Class: II Product Code: IYN and IYO Dated: May 4, 2012 Received: May 8, 2012

Dear Ms. Scott:

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 7348 Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

7348 (Modified 7340)	7348 - LA522	7348 - 5 CW
7348 - PA230	7348 - LA523	7348 - EC1123
7348 - PA122	7348 - CA123	7348 - IOE323
7348 - PA023	7348 - CA431	7348 - LP323
7348 - LA435	7348 - 2 CW	7348-TEE132

MAY 2 3 2012

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

7348 - TEE022

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 Jeffrey Ballyns at (301) 796-6105.

Sincerely Yours.

Michael D'Vlker fan

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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

Model 7348 (Modified 7340)

Indications for Use

Special 510(k) Number (if known):

Device Name: 7348 Ultrasound Systems

Esaote's Model 7348 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac (adult and pediatric), Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7348 system provides imaging for quidance 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.

Prescription Use メ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 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)

Andrew D. Robb

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

510(k)Kurai384

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

48-Modified Lead (0.4%)

7348 (Modified 7340)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

・

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

New indication: P: Previosuly cleared by FDA; E:Added under Appendi

ក គ ន

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

Previously cleared via K081794.
K091009 and k1 10688

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

510K
Esaote, S.P.A.

121384

Prescription Use Only Per 21 CFR 801 Part I

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

48-PA230

7348 - PA230
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Clinical Application	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	HarmonicImaging (TEI)
Ophthalmic
Fetal	P	P	P
Abdominal					P	P
Intraoperative (Abdominal)							P
Intraoperative Neurological
Pediatric
Small Organ [1]					P
Neonatal Cephalic	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P
Cardiac [2]	P	P	P	P	P	P
Transesophageal (Cardiac)	P	P	P	P	P	P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional (includingNerve Blocking)
Musculo-skeletal Superficial (includingNerve Blocking)
Other (Urological)

Previously cleared via k I 10688

INSTITUTIONAL REVIEW BOARD

은 전 전

[3]
Combined modes are: B + M + PW +

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

510K
K121384

Pr
Part

Small Organs includes Breast, Thyroid and Testicles
Cardiac is Adult and Pediatric
Cardiac is Adult and Pediatric
Combined modes are; B • M • PW • CW • CW • CFM • PD

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

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

TO Concurrence at CCRH, Office of In Vitro Diagnostics (OIVD)

.
.
.

Page 13 of 992

48 Special 510(k) Submissio

.
.

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

448-PA122

7348 - PA 122
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

		Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [3]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Abdominal	P	P	P	P	P	P	P		P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic		P	P	P	P	P	P		P
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 (Including Nerve Blocking)
Musculo-skeletal Superficial (Including Nerve Blocking)
Other (Urological)

ASHTABULA KL10688
ASHTABULA, OHIO 44004
(440) 997-6116
INCORPORATED 4/21/1958
ASHTABULA, OHIO

Apparently clipped to K11868

Previously 15 minutes at 8900 ft. 11,000 ft.

N: New indication; P: Previosuly cleared by FDA: E:Added under Appendix E
Previously cirared via K110688

[1]
[2]
[3]
Small Prgans includes Breast, Thyroid and Testicles
Cordhac is Adult and Pediatric
Combine modes are: B + M + PW + CW + CFM + PD

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121384

Prescription Use Only P
Part D Concurrence of CD
Vitro Diagnostics

Office of In Vitro Diagnostic Device Evaluation and
510K

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

7348 Special 510(k) Submission

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

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix
Previously cleared via k 10688

Small Organs includes Breast, Thyroid and Testicles
Cardiae is Adult and Pediatric
Conchined prodes are: B + M + PW + CW + CW + CFM + PD

은 전 전

Prescription Use
Part D Concurrent

(Division Sign-Off)
In of Radiological Devices
agnostic: Device Evaluation and Safety
21384
Pre
Part

There of in Vive Univision Signonical Claudion and Safety
Office of In Vius Univisation Devices Craining and Safety
S10K_10K_10

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

concurrence of CDRH, Office of In
Vitro Diagnostics (OIVD)

48 Special 510(k) Submissio

Page 15 of 992

7348 - PA023

. _

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

8-PA023

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

B-1435

7348 - LA435
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined [3]
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric		P	P	P	P	P
Small Organ [1]	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
Laparoscopic		P	P	P		P
Musculo-skeletal Conventional (including Nerve Blocking)	P	P	P	P		P
Musculo-skeletal Superficial (including Nerve Blocking)	P	P	P	P
Other (Urological)		P	P	P
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

PRIVACY CLEARED VIA R10056

、・

ല ഒരു ഇ

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

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

(Division of Hadiological Davice Exellention and Selection of Provinces
Office of In Vitro Diagniostic Device Exelunition and Selecty
Office of In Viro Diagniostic Device Ext

unp

5:0K T

Page 16 of 992

Esaote, S.p.A.

48 Special 510(k) Submissio

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

848-LA522

7348 - LA522
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	Combined[3]	TissueVelocityMapping(TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]			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		P
Musculo-skeletal Conventional(Including Nerve Blocking)
Musculo-skeletal Superficial(Including Nerve Blocking)
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix

N: New indication; P: Previosuly cleared by FDA; E:Added unde

Previously cleared via k11068

ਤ ਕੁ ਕੁ ਨੁ .

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

Prescription Use Only Per 21 CFFR 801
Part D Concurrence of CDRH, Office of In

2/2

Office of In Vitro District Director of Rediological Davice en Micro Betweet of the States
Office of In Vitro District Device Evralianion and States

48 Special 510(k) Submissi

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

、 Page 18 of 992

48 Special 510(k) Submission

Esaote, S.p.A.

48114523

7 348 - L A 523
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [3]	Tissue Velocity Mapping	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P
Abdominal		P	P
Intraoperative (Abdominal)							P		P
Intraoperative Neurological							P		P
Pediatric	P	P	P		P	P	P		P
Small Organ [1]	P	P	P		P	P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular							P		P
Peripheral Vascular	P	P	P		P	P	P		P
Laparoscopic
Musculo-skeletal Conventionalincluding Nerve Blocking]	P	P	P		P	P	P		P
Musculo-skeletal SuperficialIncluding Nerve Blocking]	P	P	P		P	P	P		P
Other (Urological]

N: New indication; P: Previosuly cleared by FLA; E:Added under Appendix E
Previously cleared via kl 10688

. ·

Small Organs includes Breast, T

Cardiac is Adult and Pediatric

Combined prodes are: B + M + pv

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro, Diagnostic Device Evaluation and Safety

510K. K121384

Sardiac is Adult and Pediatric
Cardiac is Adult and Pediatric
Combined modes are: II + M + PW + CFM + PD

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

Cardiac is Adult and Pediatric
Combined modes are: B + M + PW +

Cardiac is Adult and Pediatric
Combined models are: B + M +

Cardiac is Adult and Female
Combined grades are: B + N

Cardiac is Adult and Pediatric
Combined modes are: B +

Cardiac is Adult and Pediatric
Combined modes are: B + M

Combined probes are: B + R + M

Combined modes are: R + N

cardiac is than and I. Combined nodes are: B +

Small Organs includes Breast, Thyroid and Testicles

Cardiac is Adult and Pediatric

Combined nodes are: R + N

Cardiac is Adult and Pediatric
Combined nodes are: B + M +

Cardiac is Adult and Pediatric
Combined probes are: B + M + S

Combined models are: B + N

Cardiac is Adult and Pediatric.
Combined grades are: B +

Cardiac is Adult and Pediatric
Combined modes are: D + M + PW

Surah Organs includes Breast, Thyroid and
Cardiac is Adult and Pediatric
Combined probes are: B + M + PW + CFM

Cardiac is Adult and Pediatric
Combined modes are: B + M + PW

Cardiac is Adult and Pediatric
Combined modes are: D + M +

Cardiac is Adult and Pediatr
Combined modes are: B + M

Cardiac is Adult and Pediatric
Combined nodes are: R + N

Cardiac is Adult and Pediatric
Combined modes are: B + I

Cardiac is Adult and Pediatric +
Combined modes are: B +

Cardiac is Adult and Pediatric
Combined modes are: B + M

Cardiac is Atrial and Pediatric
Combined modes are: B + M + PW

Cardiac is Adult and Pediatric
Combined probes are: D + M + p

Combined models are: B + M + PW +

Combined models are: R + M + PW + CF

Cardiac is Adult and Pediatric
Combined modes are; D + M + PW

Cardiac is Adult and Pediatric
Combined modes are: B + M + PW + CFM

Cardiac is Atrial and Ventricular
Combined modes are: B + M + PW +

Cardiac is Adult and Pediatric
Combined modes are: B + M + py

Cardiac is Adult and Pediatric
Combined modes are; D + M +

Cardiac is Adult and Pediatric
Combined modes are: П + M + PW +

Cardiac is Adult and Pediatric
Combined probes are: D + M + pw

Cardiac is Adult and Pediatric
Combined modes are: B + M + PW

ue to think tank funding.
Combined nodes are: R + M +

Cardiac is Adult and Pediatric
Combined modes are: B + M + S

Cardiac is Adult and Pediatric
Combined modes are: R + M + PW + C

Cardiac is Adult and Pediatric
Combined nodes are: D + M + P

Cardiac is Adult and Pediatric
Combined modes are: B + M + pw

Combined nodes are: D + M + PW

Cardiac is Adult and Pediatric
Combined modes are: D + M + E

Cardiac is Adult and Pediatric
Combined nodes are: D + M + S

Cardiac is Adult and Pediatric
Combined prodes are: D + M + p

Cardiac is Adult and Pediatric
Combined modes are: B + M + PW

Combined modes are: B + M + PW + CFI

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

Combined modes are: B + M + PY + C

Cardiac is Adult and Pediatric
Combined modes are: D + M + Py +

Combined modes are: R + M + py

Cardiac is atrial and regular.
Combined nodes are: B + M + PW + C

Cardiac is Adult and Pediatric
Combined modes are: B + M + py

Cardiac is Adult and Pediatric
Combined modes are: B + M + PW +

Cardiac is Adult and Pediatric
Combined modes are: B + M + PW + C

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

7348 - CA123

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [3]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P
Small Organ [1]	P	P	P		P	P	P		P
Neonatal Cephalic	P	P	P		P	P	P		P
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via ki 10688

Musculo-skeletal Conventional
(including Nerve Blocking)
Musculo-skeletal Superficial
Jincluding Nerve Blocking)

Other (Urological)

ರ

Peripheral Vascular

Laparoscopic

lel
Mi
Mi

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

udhush

College of the Division of Hadinlogices Devices
Office of in Division ot Hadinlogices Devices
Office of in Vitro Diagnosiice Devices Eveluption and Safety

Prescription Use Only Per 21 CFFR 801

48 Special 510(k) Submission

Esaote, S.p.A.

510K-

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

Other |specify Harmonic
Imaging (TEI d ﮮ ﮯ น พ.ศ. 2016 เมตรี และ ค.ศ. 1989 เมตรี และ ค.ศ. 1989 เมตรี และ ค.ศ. 1989 เมตรี และ ค.ศ. 1989 ค.ศ. 1999 ค.ศ. 1999 ค.ศ. 1999 ค.ศ. 1999 ค.ศ. 1999 ค.ศ. 1999 ค.ศ. 1999 ค.ศ. 1997 ค Combined
ీ ﻟﺘﻌ Mode of Operations Amplitude
Doppler P Color
Doppier ﮯ P ﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ ב CWD PWD ﺣ d ﮮ N d d b ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ ല് ﮯ ﺣ ﮯ ﻟﯿﮯ ત ત ﻜ Transesophageal (Non Cardiac Musculo-skeletal Conventionalincluding Nerve Blocking| Musculo-skeletal Superficial
Including Nerve Blocking ntraoperative Neurological ransesophageal (Cardiac) ntraoperative (Abdominal Clinical Application Peripheral Vascular Neonatal Cephalic
Adult Cephalic Other (Urological) Small Organ [1] Transurethral întravascular Transvaginal Dphthalmic fransrectal Cardiac (2) ibdominal Pediatric Fetal

Stiller (0.00g Bay
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix"
Previously cleared via k1 10688

MODELS DA MARCA VIA MODENA

Prescription Use Only Per 21 CFFR 801
art D Concurrence of CDRH, Office of In
Vitro Diagnostics (OlVD)

Convision Division Bign: Division Biggion Corporation Corporation
Office of in Vitro Diagnostic Devices Evaluation and Sater

and

ਕ ਕੁ ਕੁ

1381

510K-

Esaote, S.p.A

7218 Special 510(K) Submission

-CA431

7 348 - CA431
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

aparoscopic

mail Organs includes Breast, Thyroid and Testic
ardiac is Adult and Pediatric
ombined modes are: B + M + PW + CFM + PD

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

48-2CM

7 348 - 2 CVV
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TissueVelocityMapping(TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]				p
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventionalincluding Nerve Blocking
Musculo-skeletal SuperficialIncluding Nerve Blocking)
Other (Urological)

មួយ Previously cleared via kt 10688

[1]
121
Small Organs includes Brenst, Thyroid and Testicles
Cardin is Adult and Pediatric

(Division Sign-OH)
Division of Radiological Devices
Office of In Vitro, Diagriostic Ouvice Evaluation and Safety
STOK K121384
510K
Prescription Use Onl
D Concurrence of C
Diagnost

.
Prescription Use Only Per 21 CFR 801 Part
D Concurrence of CDRH, Office of In Vitro

348 Special 510(k) Submission

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

348-CCW

7 348 - 5 CVV
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	Combined[3]	TissueVelocityMapping(TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(Including Nerve Blocking)
Musculo-skeletal Superficial(Including Nerve Blocking)
Other (Urological)
New indication: P. Previously cleared by FDA; E:Added under Appendix E

Previously cleared via k l 10688

ដែរ
លោក នៅ ដោ

Small Organs includes Breast, Thyroid and Testicles

Cardiac is Adult and Pediatric

1100
(Division Sign-Off)
sion of Radiological Devices

Prescription Use O
D Concurrence of

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K.

K121384

Prescription Use Only Per 21 CFR 801 Part
D Concurrence of CDRH, Office of In Vitro

348 Special 510(k) Submission

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

8-EC1123

7348 - EC1123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined[3]	HarmonicImaging (TEI)
Ophthalmic
Scrotal	P	P	P	P		P	P
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(Including Nerve Blocking)
Musculo-skeletal Superficial(Including Nerve Blocking)
Other (Urological)	P	P	P	P	P	P	P

N: New indication; P. Previously Previously Previously cleared via K110688

previously cleared via K110688

Bilateral Organism
Cardiac is Adult and
Combined index a

트 프로드 프 .`

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

Combined model are:

Division of the...

This of In Division of Historian Collection and Select
Office of In Division of Finalistical Division and Select

Prescription Use Only Per 21 CFFR 801
Part D Concurrence of CDRH, Office of In

Esaote, S.p.A.

Page 23 of 992

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

18-IDE323

7348 - IOE323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human been follows of the of S

Clinical Application	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [3]	Harmonic Imaging (TEI)
Ophthalmic
Fetal
Abdominal	p	p	p	p	p	p
Intraoperative (Abdominal)	p	p	p	p	p	p
Intraoperative Neurological	p	p	p	p	p	p
Pediatric	p			p	p	p
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]		p	p	p	p	p
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		p			p		p
Laparoscopic
Musculo-skeletal Conventional (including Nerve Blocking)	p						p
Musculo-skeletal Superficial (including Nerve Blocking)	p						p
Other (Urological)	p						.

Previously cleared via k1 10688

January Created via NY900

111

Small Organs includes Breast, Thyroid and Testicles

Cardiac is Adult and Pediatric

Combined modes are: B + M + PW + CFM + PD

Ama

Office of in Vitro Disgnion Bign-Off Devices
Office of in Vitro Diagnostic Devices Eveluation and Safoty

80 ﮐﮯ C 510K B

Esaote, S.p.A.

Prescription Use Only Per 21 CFR 801
Part D Concurrence of CDRH, Office of In .

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

48.-LP323

7348 - LP323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows of the local

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined[3]	HarmonicImaging (TEI)
Ophthalmic
Fetal	P
Abdominal		P	P	P	P	P	P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic		P		P		P
Musculo-skeletal Conventional(Including Nerve Blocking)			P		P		P
Musculo-skeletal Superficial(Including Nerve Blocking)							P
Other (Urological)

Previously cleared via K110688

Small 0.7
Cardiac 1.0

은 조 조

Small Organs includes Breast, Thyroid and Testicles

Cardiac is Adult and Pediatric

Combined modes are: B + M + PW + CFM + PD

Alley

Office of In Viro Diagnostic Device Councilland States
Office of In Viro Diagnostic Device Councillor and States
Colice of In Viro Diagnostic Device Evantion and Statesy
S10K

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

Esaote, S.p.A.

348 Special 510(k) Submission

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

348.-1EE132

7 7 48 - T EE 1 32
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	Combined[3]	TissueVelocityMapping	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)		P	P	P	P	P	P		P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional (includingNerve Blocking)
Musculo-skeletal Superficial (includingNerve Blocking)
Other (Urological)
New indication: P: Previously cleared by FDA; E:Added under Appendix E

y. cleared N: New indication; P: Previosuly
Previously cleared via K110688

[1]
[2]
[3]
(Division Sign-Off)
Division of Radiological Devices
Small C
Cardiac
Office of In Vitro Diagnostic Device Evaluation and Safety
STOK K121384
510K.

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

Prescription Use Only Per 21 CFFR 80

Esaote, S.p.A.

510K -

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

48-TFE022

7 348 - TEEO22
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	Combined[3]	TissueVelocityMapping	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Total
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)	P	P	P	P	P	P	P		P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial (includingNerve Blocking)
Other (Urological)
New indication; P: Previously cleared by FDA; E:Added under Appendix E

. .

Previously cleared via K110688

드 프로그램
[1]
[1]

Small Organs includes Breast, Thyroid and Testicles
Cardiac is Adult and Pediatric
Combined modes arc: B + M + PW + CW + CFM + PIJ

(Division Sign-Of)
Division of Radiological Devices
of In Vitro Diagriostic Device Evaluation and Saf

Prescription Use Only Per 21 CFFR 801
Part D Concurrence of CDRH, Office of In

Significal of Readiongical Device Erailustion and Safaty
Office of In Vitin Disagriostic Device Erailustion and Safaty
Office of In Vitro Disagrios tic Diviso Erailustion and

Esaote, S.p.A.

18 Special 510(k) Submissi

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.