Esaote's Model 7348 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, 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

Model 7348 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, Tissue Enhancement Imaging (TEI), Multi View (MView), CW and PW Doppler, Color Flow Mapping (CFM) and Amplitude Doppler (AD). 7348 is equipped with a LCD color display where acquired images and advanced image features are shown. 7348 can drive Phased, Convex, Linear array and Doppler probes. Model 7348 has been designed to be powered by battery.

7348 has been previously cleared via K121384.

7348 Upgrade, defined herein, combine the cleared features of 7348 system with new software capabilities, listed below:

Managing of Tissue Velocity Mapping (TVM) and Tissue Velocity (TV) mode. 1.
1. Managing of M-Mode with free positioning of the acquisition line (Compass M-Mode).
Management of Stress Echo where detection of the occurrence of stress-induced wall motion 3. abnormalities is derived through comparison of 2D loops, displaying wall motion at rest and during and after stress.
Management of Intima Media Thickness to automatically measure the thickness between the 4. intima and the media on the image in real time.

The 7348 Upgrade is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Esaote 7348 Ultrasound System Upgrade). It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria or a study proving the device meets them in the context of clinical performance metrics.

Specifically, the document states:

"Summary of Clinical Tests: No clinical tests were performed." This explicitly indicates that no studies were conducted to assess clinical performance using test sets against acceptance criteria.
The entire submission relies on technological equivalence to previously cleared devices (7348 cleared via K121384 and 7340 via K081794, K091009, K110688) for its functionalities, including the new software capabilities (Tissue Velocity Mapping (TVM) and Tissue Velocity (TV) mode, Compass M-Mode, Stress Echo management, and Intima Media Thickness measurement).

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets them from the given text.

Here's why and what information is missing:

Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document focuses on comparing the new features to existing, cleared equivalent features on predicate devices, rather than defining specific performance metrics and showing test results.
Sample Size Used for the Test Set and Data Provenance: No test set was used for clinical performance evaluation since "No clinical tests were performed."
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable, as no clinical tests were performed requiring ground truth establishment by experts for a test set.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no clinical studies were performed.
Standalone Performance: While the device has technological characteristics, no standalone clinical performance study was done as per the document. The capabilities (e.g., TVM, Compass M-Mode) are stated to be "equivalent to" those of the predicate device, which implies their performance is assumed to be similar based on "technological characteristics."
Type of Ground Truth Used: Not applicable.
Sample Size for the Training Set: Not applicable, as this is not an AI/ML device in the modern sense requiring a training set for clinical performance. The "new software capabilities" are presented as features equivalent to those already present in predicate devices.
How the Ground Truth for the Training Set was Established: Not applicable.

Summary

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APR 2 5 2014

K140677
Page 1 of 3

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

Contact Person:

Allison Scott 317.228.8719 allison.scott@navigant.com

Date:

March 17, 2014

807.92(a)(2)

Devices

Common Name:	Ultrasound Imaging System
Trade Name:	7348 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)
7348	Esaote	K121384
7340	Esaote	K081794, K091009,
		K110688

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

807.92(a){4)

Device Description

7348 has been previously cleared via K121384.

7348 Upgrade, defined herein, combine the cleared features of 7348 system with new software capabilities, listed below:

Managing of Tissue Velocity Mapping (TVM) and Tissue Velocity (TV) mode. 1.
1. Managing of M-Mode with free positioning of the acquisition line (Compass M-Mode).
Management of Stress Echo where detection of the occurrence of stress-induced wall motion 3. abnormalities is derived through comparison of 2D loops, displaying wall motion at rest and during and after stress.
Management of Intima Media Thickness to automatically measure the thickness between the 4. intima and the media on the image in real time.

The 7348 Upgrade is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use

807.92(a)(6)

Technological Characteristics

The 7348 Upgrade employs the same fundamental technological characteristics as their predicate devices. The 7348 Upgrade model is substantially equivalent to Esaote 7348 model cleared via K121384, and to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.

· Clinical uses for which Esaote 7348 model, cleared by FDA via K121384, are designed are not changed by 7348 Upgrade, to be cleared via this submission.

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

K140677
page 3 of 3

· Clinical uses for which Esaote 7348 Upgrade is designed are equivalent to those of Esaote 7348 model cleared via K121384, and to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
7348 upgrade for managing Tissue Velocity Mapping (TVM) and Tissue Velocity (TV) mode is equivalent to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
· 7348 upgrade for managing M-Mode with free positioning of the acquisition line (Compass M-Mode) is equivalent to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
· 7348 upgrade for managing Stress Echo, where detection of the occurrence of stress-induced wall motion abnormalities is derived through comparison of 2D loops, displaying wall motion at rest and during or after stress, is equivalent to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
· 7348 upgrade for managing Intima Media Thickness to automatically measure the thickness between the intima and the media on the image in real time , is equivalent to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
Esaote 7348 Upgrade, 7348 and 7340 ultrasound models are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
· Esaote 7348 Upgrade, 7348 and 7340 ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.

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 7348 Upgrade is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

{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 a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

April 25, 2014

Esaote S.P.A. % Allison Scott Senior Consultant 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K140677 Trade/Device Name: 7348/MyLabSogno Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 17. 2014 Received: March 18. 2014

Dear Ms. Scott:

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. Ilisting 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 MylabSogno, as described in your premarket notification:

Transducer Model Number
PA230	CA123	IOE323
PA122	CA431	LP323
PA023	2 CW	TEE132
LA435	5 CW	TEE022
LA522	HFCW
LA523	EC1123

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

Page 2-Ms. Scott

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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Smh.7)

for

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140677

Device Name 7348/MyLabSogno

Indications for Use (Describe)

Estole's Model 7.48 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophaged Cardiac, Peripheral Vascular, Neonalic, Adult Ceplalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Feal, Transresal, Pediatic, Intraoperative abdominal, Laparoscopic and Other: Urologic, The 7.48 system provides innaging 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)

[ሬ] Prescription Use (Parl 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)

Sm)

FORM FBSaBBoRD(1784) Upgrade 510(k)

Page Baladin 1932 " " " 11 -a" w

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

7348 Upgrade

Intended 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	Combined [3]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)
Ophthalmic
Fetal	P	P	P		P	P	P		P
Abdominal	P	P	P	P	P	P	P		P
Intraoperative (Abdominal)	P	P	P		P	P	P		P
Intraoperative Neurological
Pediatric	P	P	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		P
Adult Cephalic	P	P	P	P	P	P	P		P
Cardiac [2]	P	P	P	P	P	P	P	N	P
Transesophageal (Cardiac)	P	P	P	P	P	P	P	N	P
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P		P
Transvaginal	P	P	P		P	P	P		P
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P
Laparoscopic	P	P	P		P	P	P		P
Musculo-skeletal Conventional(including Nerve Blocking)	P	P	P		P	P	P		P
Musculo-skeletal Superficial(including Nerve Blocking)	P	P	P		P	P	P		P
Other (Urological)	P	P	P		P	P	P		P

N: New indication; I': Previosuly cleared by FDA; E:Added under Appendix E

Small Organs includes Breant, Thyroid and Testicles 비 시 Cardiac is Adult and Pediatric Combined modes arc: B + M + PW + CW + CFM + I'D

Previously cleared via k 121384

|3|

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

・

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

7348 - PA230

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

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

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

Previously cleared van K121384

וי ו 121 (3)

Small Organs includes Breast. Theroid und Testicles Cardiac in Adult and Pedialric Combined modes are: B + M + PW • CW + CFM + PD

Prescription Use Only Per 21 CFR 801 Parl D Concumence of CDRH

.

. 1

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

7348 - PA122

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TissueVelocityMapping(TVM)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P
Small Organ [1]
Neonatal Cephalic	P	P	P	P	P	P	P
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	N
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)

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

FOR YOUR HEALTH AND WELL-BEING

Previously cleared via K121384

ויין |김 Small Organs includes Breast. Theroid and Testicles

Cardiac is Adult and Fetal.

리가

Cardiac is Adult and Pediatric

Combined modes are: H + M + PW + CW + CliM • 14)

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

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

7348 - PA023

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

Clinical Application	H	M	IWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P
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)

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

Previously cleared via k l 2 1 384

ויין 기

131

Small Organs includes Breast, Thyoid and Testicles Cariliar in Adult and Pediatric

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

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

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

7348 - LA435

Clinical Application	Mode of Operations
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TissueVelocityMapping(TVM)	HarmonicImaging (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
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	P	P	P		P	P	P
Musculo-skeletal Superficial(including Nerve Blocking)	P	P	P		P	P	P
Other (Urological)

R. verify alerted via 8/12/2021

Previously cleared via K132231

Small Organs includes Breast, Theroid and Testicies ווין Cardiac is Adult and Pediatric 12| Combined modes nre: B + M • I'W • CFM • I'W 기

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

·

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

7348 - LA522

Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [3]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
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
Peripheral Vascular	P	P	P		P	P	P		P
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication: P Previosuly cleared by FDA: E:Added under Appendux E

Previously cleared via k L2 L384

ររ Small Organs meludes Breast, Thyroid and Testicles (2) Cardus is Adult and Priliatio 1가 Combined modes are: H + M • PW • CI·M • PI>

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

・

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

7348 - LA523

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined [3]	Harmonic Imaging (TEI)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
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
Peripheral Vascular	P	P	P	P	P	P	P
Laparoscopic
Musculo-skeletal Conventional (including Nerve Blocking)	P	P	P	P	P	P	P
Musculo-skeletal Superficial (including Nerve Blocking)	P	P	P	P	P	P	P
Other (Urological)

N: New indication; I': Previosulv cleared by FDA; E:Added under Appendux F

Previously cleared vin K132466

시

1-31

Small Organs meludes Breast, Theroid and Testicles ויין

Cardiac is Adult and Pedialrir

Combined modes are: B・M・TW ・ CFM ・ F1)

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

Esaale SpA 7348 Upgrade 510(k)

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

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		P
Small Organ [1]	P	P	P		P	P	P		P
Neonatal Cephalir	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)	P	P	P		P	P	P		P
Musculo-skeletal Superficial (including Nerve Blocking)	P	P	P		P	P	P		P
Other (Urological)

7348 - CA123
Intended use: Diagostic ultrasound imaging or fluid flo alvsis of hr n body as follows

N: New Indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K121384

|| ||

Small Organs includes Breast. Thyroid and Testicles 111

(2) Cardiac is Adult and Pediatre

Combined modes arc: B + M + TW + CFM + FD

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

. . . . . .

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

7348 - CA431

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:Clinical Application	Mode of Operations
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TissueVelocityMapping(TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P
Abdominal	P	P	P		P	P	P		P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P
Small Organ [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
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	P	P	P		P	P	P		P
Musculo-skeletal Superficial(including Nerve Blocking)	P	P	P		P	P	P		P
Other (Urological)	P	P	P		P	P	P		P

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

N: New indication: P: Previosuly viened by FDA; 1:Added under Appendix E

Previously cleared via K121384

(リ) |가 |과 Small Organs includes Breast, Thyroxl and Tosticles Cardiac is Adult and Pediatric Combined modes are: 13 + M + PW + CFM + IPD

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

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

7348 - 2 CW

Clinical Application	Mode of Operations
	B	M	FWD	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 Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

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

Previously cleared via k l 21,384

미

(2)

Small Organs includes Breast, Thysoid and Testicles

Cardiac is Adult and Pediatric

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

Esacte SpA 7348 Upgrada 510(k)

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

7348 - 5 CW	Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	Mode of Operations									Other (specify)
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TissueVelocityMapping(TVM)	HarmonicImaging (TEI)
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				P
Laparoscopic
Musculo-skeletal Conventionalincluding Nerve (Blocking)
Musculo-skeletal Superficialincluding Nerve Blocking)
Other (Urological)

N: New indication: P: Previosuly cleared by FDA: E:Addrd under Appendix E

Previously cleared vin K121384

ווי נ (2) Small Organs includes Breast. Thyroid and Testicles Cardiac is Adult and Pediatric

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

.

Esaolo SpA 7348 Upgrada 510(k)

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

	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)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

Previously cleared via k 1 10688

ן נו

្រើ

Small Organs includes Breast, Thyruid and Testicles Cardiac is Adult and Prdiatric

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

: 、

: .

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

7348 - EC1123

Clinical Application	Mode of Operations								Other (specify)
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(3)	TissueVelocityMapping(TVM)	HarmonicImaging (TEI)
Ophthalmic
Fetal	P	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: Previosuly cleared by FDA: E:Added under Appendix E

Previously cleared via k13223 !

い

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

Prescription Use Only Per 21 CFR 801 Parl D Concurrence of CDRH .

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

7348 - IOE323
Intended use Diagno

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined[3]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P
Intraoperative (Abdominal)	P	P	P	P	P	P
Intraoperative Neurological
Pediatric	P	P	P	P	P	P
Small Organ [1]	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
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	P	P	P	P	P	P
Musculo-skeletal Superficial(including Nerve Blocking)	P	P	P	P	P	P
Other (Urological)

N: New indication: P. Previosuly cleared by FDA, E:Added under Appendix E.

Previously cleared via k | 21384

= Small Organs includes Brennt, Thyronl and Testicles ្រា Cardiac is Adult and Pedialnr Combined modes are: B + M + IªW + CI·M + I'D |3|

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

Essolo SpA 7348 Upgrado 510(k)

・

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

7348 - LP323

	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	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		P	P	P
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

stic uttra alysis of human body as folk nd imaging or fluid flo

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

Previously cleared via kl 21384

111

Small Organs includes Breast. Theroid and Testicles

기 ાગ Cardial in Adult and Prihatra

Combined modex are, B · M · FW · (FM · PD 1 - 1 - 1 - 1 - 1

・

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

で、

. .

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

7348 - TEE132

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TissueVelocityMapping	HarmonicImaging (TEI)
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	N	P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional includingNerve Blocking)
Musculo-skeletal Superficial includingNerve Blocking)
Other (Urological)

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

N: New indication; I': I'remosuly cleared by FDA: E:Added under Appendix E

Previously cleared via K121384

ון ניין 기 131 Small Organs includes Breinst, Theroid and Testiclex Cardiac is Adult and Pediator Combined modes are: Ft + M • PW • CW • CFM • PD

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

.

. : .

Page 50 of 1032

Esaolo SpA 7348 Upgrade 510(k)

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

7348 - TEE022

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	HarmonicImaging (TEI)
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	P	P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional (includingNerve Blocking)
Musculo-skeletal Superficial (includingNerve Blocking)
Other (Urological)

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

Previously cleared via k121 J84

1	1

	21
1

Small Organs includes Breast. Theroul and Testicles Cardiac is Adult and Pediatric Combined modes are: fi + M · PW · CW · CFM · PD

ાંગ

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

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.