Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic.

Esaote's Model 7350 (MyLab50) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic.

Esaote's Model 6150 (MyLab70) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic.

Esaote's Model 6100 (MyLab90) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Adult Cephalic, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.

Device Description

The 7300 (MyLab30), 7350 (MyLab50), 6150 (MyLab70), and 6100 (MyLab90) system designs remain the same as those previously cleared by FDA via K040596, K050326, K051308, and K051837, respectively. They are ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.

The 30/50/70/90 systems are able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The systems in combination with the BC431 or BS230 probes, offer the possibility to also produce automatic 3D and Real Time 4D images. The 7300 (MyLab30), 7350 (MyLab50), 6150 (MyLab70), and 6100 (MyLab90) models are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

AI/ML Overview

The provided text does NOT describe specific acceptance criteria and a study to prove they are met. Instead, it is a 510(k) Summary, which is a premarket notification to the FDA. It outlines the device's characteristics and its substantial equivalence to previously cleared devices.

Therefore, most of the requested information cannot be extracted from this document, as a 510(k) summary primarily focuses on demonstrating equivalence rather than detailing rigorous performance studies with specific statistical metrics and ground truth establishment.

Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against defined acceptance criteria. The tables in the original text show which modes and applications are "new" (N) or "previously cleared" (P) for different models and transducers, comparing them to predicate devices, but do not contain numerical performance data or acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not present. No details about a specific test set, its sample size, or data provenance (country, retrospective/prospective) are mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not present. Establishing ground truth is typically part of a performance study, which is not detailed here.

4. Adjudication Method

This information is not present.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not present. There is no mention of a comparative effectiveness study, nor any effect sizes for human reader improvement with or without AI.

6. Standalone (Algorithm Only) Performance Study

This information is not present. The device is an ultrasound imaging system, not a standalone algorithm in the AI sense. Its "performance" would relate to image quality and diagnostic capability, which are typically assessed through clinical use and comparison to established methods, rather than an "algorithm only" study.

7. Type of Ground Truth Used

This information is not present.

8. Sample Size for the Training Set

This information is not present. The document does not describe the development or training of any AI/algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not present.

Summary of Device and Equivalence Claim:

The document describes the MyLab30, 50, 70, 90 Systems by Esaote, S.p.A. as ultrasound imaging systems. The 510(k) submission aims to gain clearance for these systems, specifically for the addition of certain functionalities and transducers.

The core of the submission is to demonstrate substantial equivalence to several predicate devices, including:

K040596: 7300 (MyLab30)
K050326: 7350 (MyLab50)
K051308: 6150 (MyLab70)
K051837: 6100 (MyLab90)
K043455: 8000Live (Medison)
K022567: Sequoia Signature II (Siemens)

The new elements for which clearance is sought are primarily:

The addition of 3D/4D imaging capabilities.
The addition of specific transducers (BC431 and BS230) and biopsy accessories for them.
New "Urological" indication for some models.

The tables indicate which functionalities are "new" (N) to the specific model/transducer combination being reviewed in this 510(k) and which were "previously cleared" (P) by the FDA on other models or previous submissions. The substantial equivalence claim is based on the device having the same intended use, similar technological characteristics, and being as safe and effective as the predicate devices. The FDA's letter (sections 3-5) confirms the determination of substantial equivalence for the specified models with the added transducers.

Summary

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

K060827

WW 19

510(k) Summary MyLab30, 50, 70, 90 Systems Esaote, S.p.A.

510(k) Summary

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

807.92(a)(1)

Submitter Information

Carri Graham, Official Correspondent The Anson Group 11460 N Meridian St., Ste 150 Carmel, Indiana 46032 Phone: (317) 569-9500 x103 Facsimile: (317) 569-9520

Contact Person:	Carri Graham
Date:	March 24, 2006
807.92(a)(2)
Trade Name:	MyLab30, 50, 70, 90 Systems
Common Name:	Ultrasound Imaging System
Classification Name(s):	Ultrasonic pulse doppler imaging system 892.1550Ultrasonic pulsed echo imaging system 892.1560
Classification Number:	90IYN; 90IYO

807.92(a)(3)

Predicate Device(s)

K040596	7300 (MyLab30)	Esaote, S.p.A.
K050326	7350 (MyLab50)	Esaote, S.p.A.
K051308	6150 (MyLab70)	Esaote, S.p.A.
K051837	6100 (MyLab90)	Esaote, S.p.A.
K043455	8000Live	Medison
K022567	Sequoia Signature II	Siemens

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

510(k) Summary MyLab30, 50, 70, 90 Systems Esaote, S.p.A.

807.92 (a)(4)

Device Description

807.92(a)(5)

Intended Use(s)

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

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	SiemensSequoiaSignature IIK022567(Predicate)	Medison8000LiveK043455(Predicate)	EsaoteMyLab90(6100)K051837(Predicate)	EsaoteMyLab70(6150)K051308(Predicate)	EsaoteMyLab30CV(7300)K040596	EsaoteMyLab50(7350)K050326
3D Mode			✔	✔	YES	YES
4D Mode			✔	✔	YES	YES
Strain Rate			YES	YES	YES	YES
Quantification			YES	YES	YES	YES
Biopsy Accessories	NO	NO	YES	YES	YES	YES
ABC43	NO	NO	YES	YES	YES	YES
Biopsy Kit for BS230	NO	NO	YES	YES	YES	YES
Transducers	NO	NO	YES	YES	YES	YES
BC431	NO	NO	YES	YES	YES	YES
BS230	NO	NO	YES	YES	YES	YES
Indication For Use	NO	NO	✔	✔	YES	YES
Urologic	NO	NO	✔	✔	YES	YES
IMT.LAB Software*	NO	NO	✔	✔	YES	YES

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*IMT.LAB software was cleared via K043360 and runs on a stand-alone PC.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2006

Esaote, S.p.A. % Ms. Carrie Graham Consultant Anson Group, LLC 11460 N Meridian St., Ste 150 CARMEL IN 46032

Re: K060827

Trade Name: MyLab30, 50, 70, 90 Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 24, 2006 Received: March 27, 2006

Dear Ms. Graham:

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 Model 7300 (MyLab30) and 7350 (MyLab50) systems with the added BS230 and BC431 ultrasound transducers and the Model 6150 (MyLab70) and Model 6100 (MyLab90) systems with the added BC 431 ultrasound transducer.

Image /page/3/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular emblem with the letters "FDA" in the center, surrounded by the words "Centennial" and "1906-2006". Below the logo, the words "Protecting and Promoting Public Health" are written in a cursive font. The logo is black and white.

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

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 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); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Marvland 20850

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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

Page 3 - Ms. Graham

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If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure(s)

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

Indications for Use

510(k) Number (if known): K 060827

MyLab30, 50, 70, 90 Systems addition of 3D/4D Device Name:

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) ANDIOR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

Nancy C. broglon

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K060822

	Page 1 of 1
--	-------------

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

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Model 7300 (MyLab30)

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P [2]	P [3], N[4]
Abdominal		P	P	P		P	P		P [2]	P [3], N[4]
Intraoperative(Abdominal)		P	P	P		P	P		P [2]	P [3]
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		P [2]	P [3], N[4]
Small Organ (specify) [1]		P	P	P	P	P	P		P [2]	P [3]
Neonatal Cephalic		P	P	P	P	P	P		P [2]
Adult Cephalic		P	P	P	P	P	P		P [2]
Cardiac		P	P	P	P	P	P		P [2]	P [3], N[4]
Transesophageal		P	P	P	P	P	P		P [2]
Transrectal		P	P	P		P	P		P [2]
Transvaginal		P	P	P		P	P		P [2]
Transurethral
Intravascular
Peripheral Vascular		P	P	P	P	P	P		P [2]
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		P [2]
Musculo-skeletalSuperficial		P	P	P	P	P	P		P [2]
Other (Urological)		N	N	N	N	N	N		N [2]

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

Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles.
{2} Applicable combined modes: B+M+PW+CW+CFM+PD
[3] Tissue Enhancement Imaging (TEI)
- Compound Imaging

VPAN

Tissue Velocity Mapping (TVM)
CMM
CnTI
[4] 3D/4D Imaging

PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hogdon

(Division Sign-Off) Division of Reproduc and Radiological Device 510(k) Number

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

2017-12-12 17:00 PM 15-12-2017

Model 7350 (MyLab50)

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P [2]	P [3], N[4]
Abdominal		P	P	P		P	P		P [2]	P [3], N[4]
Intraoperative(Abdominal)		P	P	P		P	P		P [2]	P [3]
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		P [2]	P [3], N[4]
Small Organ (specify) [1]		P	P	P	P	P	P		P [2]	P [3]
Neonatal Cephalic		P	P	P	P	P	P		P [2]
Adult Cephalic		P	P	P	P	P	P		P [2]	P [3]
Cardiac		P	P	P	P	P	P		P [2]	P [3], N[4]
Transesophageal		P	P	P	P	P			P [2]
Transrectal		P	P	P		P	P		P [2]
Transvaginal		P	P	P		P	P		P [2]
Transurethral
Intravascular
Peripheral Vascular		P	P	P	P	P	P		P [2]
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		P [2]
Musculo-skeletalSuperficial		P	P	P	P	P	P		P [2]
Other (Urological)		N	N	N	N	N	N		N [2]

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

[3] Tissue Harmonic Imaging (TEI)
CMM Tissue Velocity Mapping (TVM) VPAN Compound Imaging CnTI

[4] 3D/4D Imaging

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

concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801,109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060827

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

Model 6150 (MyLab70)

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P	P	P	P		P [2]	P [3], N[4]
Abdominal		P	P	P	P	P	P		P [2]	P [3, N[4]]
Intraoperative(Abdominal)		P	P	P	P	P	P		P [2]	P [3]
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		P [2]	P [3], N[4]
Small Organ (specify) [1]		P	P	P	P	P	P		P [2]	P [3]
Neonatal Cephalic		P	P	P	P	P	P		P [2]	P [3]
Adult Cephalic		P	P	P	P	P	P		P [2]	P [3]
Cardiac		P	P	P	P	P	P		P [2]	P [3], N[4]
Transesophageal		P	P	P	P	P	P		P [2]	P [3]
Transrectal		P	P	P		P	P		P [2]	P [3]
Transvaginal		P	P	P		P	P		P [2]	P [3]
Transurethral
Intravascular
Peripheral Vascular		P	P	P	P	P	P		P [2]	P [3]
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		P [2]	P [3]
Musculo-skeletalSuperficial		P	P	P	P	P	P		P [2]	P [3]
Other (Urological)		P	P	P	P	P	P		P [2]	P [3]

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

[1] Small organs include Thyroid, Breast and Testicles.
[2] Applicable combined modes: B+M+PW+CW+CFM+PD
[3] Tissue Harmonic Imaging (TEI)
- CMM

VPAN

Compound Imaging

CnTI

Tissue Velocity Mapping (TVM) 3D Imaging

[4] 4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF

concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon
(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060827

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

A the may be the comments of the state of the states

Model 6100 (MyLab90)

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P	P	P	P		P [2]	P [3], N[4]
Abdominal		P	P	P	P	P	P		P [2]	P [3], N[4]
Intraoperative (Abdominal)		P	P	P	P	P	P		P [2]	P [3]
Intraoperative Neurological
Pediatric		P	P	P	P	P	P		P [2]	P [3], N[4]
Small Organ (specify) [1]		P	P	P	P	P	P		P [2]	P [3]
Neonatal Cephalic		P	P	P	P	P	P		P [2]	P [3]
Adult Cephalic		P	P	P	P	P	P		P [2]	P [3]
Cardiac		P	P	P	P	P	P		P [2]	P [3], N[4]
Transesophageal		P	P	P	P	P	P		P [2]	P [3]
Transrectal		P	P	P	P	P	P		P [2]	P [3]
Transvaginal		P	P	P	P	P	P		P [2]	P [3]
Transurethral
Intravascular
Peripheral Vascular		P	P	P	P	P	P		P [2]	P [3]
Laparoscopic		P	P	P	P	P	P		P [2]	P [3]
Muscolo-skeletalConventional		P	P	P	P	P	P		P [2]	P [3]
Muscolo-skeletalSuperficial		P	P	P	P	P	P		P [2]	P [3]
Other (Urological)		P	P	P	P	P	P		P [2]	P [3]

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

[3] Tissue Harmonic Imaging (TEI)

CMM

VPAN

Compound Imaging

CnTI

Tissue Velocity Mapping (TVM)

3D Imaging

4] 4D Imaging

ripheral Vascular to include Vein Mapping & Scieroterapy

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEED concurrence of CDRH, Office of Device Evaluation (6

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 2060827

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

7300, 7350, 6150 and 6100 Systems

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1000 1000

Mode of Operation Clinical Application Color Amplitude Color CWD PWD Combined Other A B M Doppler Doppler Velocity (PW) (CW) (specify) (specify) (CFM) (PD) Imaging Ophthalmic Fetal N N N N N N (1) N (2), NJ3) Abdominal N N N N N N (1) N (2), NJ3] Intraoperative (specify) Intraoperative Neurological Pediatric N N N N N N (1) N (2), N/3] Small Organ (specify) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethrai Intravascular Peripheral Vascular N N N N N N (1) N (2) Laparoscopic Muscolo-skeletal Conventional Muscolo-skeletal Superficial Other (Urological) N N N N N N (1) ਮ (2)

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

[1] Applicable combined modes: B+M+PW+CFM+PD

[2] Tissue Harmonic Imaging (TEI)

CMM VPAN Compound Imaging CnTI Tissue Velocity Mapping (TVM) [3] 3D/4D Imaging

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

concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Nancy C. brogdon

(Division Sign-Off)0
0
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 4060827

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

7300 and 7350 Systems

and and the other the same of the comments of the former of

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N		N (1)	N (2), N[3]
Intraoperative (specify)
IntraoperativeNeurological
Pediatric
Small Organ (specify)						!
Neonatal Cephalic
Adult Cephalic		N	N	N	N	N	N		N (1)	N (2), N[3]
Cardiac		N	N	N	N	N	N		N (1)	N (2), N[3]
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)

BS230

Comment of the comments of the Children of the Market Home one

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

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

(2) Tissue Harmonic Imaging (TEI)

Compound Imaging

CnTI

[3] 3D/4D Imaging

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

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. hogdon

(Division Sign-Off) (Division Sign-Off, Only Division of Radiological Devices 510k) Number _

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

6150 and 6100 Systems

2012/04/2017 11:2

Auction of the

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		P (1)	P (2), N[3]
Intraoperative (specify)
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		P (1)	P (2), N[3]
Cardiac		P	P	P	P	P	P		P (1)	P (2), N[3]
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)

BS230

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

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

[2] Tissue Harmonic Imaging (TEI)
- Compound Imaging
- CnTI
3D Imaging [3] 4D Imaging

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

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-Off) (Division Sign-Only and Radiological Devices 510(k) Number _

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.