Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.

Device Description

The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes.

AI/ML Overview

The provided document, K061641, is a 510(k) Premarket Notification for the "sarano" Ultrasound Imaging System by Shimadzu Medical Systems. This document is a regulatory submission for market clearance and does not contain details about specific clinical studies or performance evaluation results against pre-defined acceptance criteria related to diagnostic accuracy or clinical effectiveness.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (Shimadzu Corporation SDU-1100 (K050510)). The performance information provided is primarily related to the device's adherence to voluntary safety and measurement standards, and its intended uses and operational modes across various transducers.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study that proves the device meets those criteria in the way you've outlined for diagnostic performance.

However, I can provide information based on the typical requirements for a 510(k) submission for an ultrasound system, which often involves compliance with recognized standards.

Here's an interpretation of the available information in the context of what would generally be considered "acceptance criteria" for this type of device and how the document implicitly "proves" they are met:

Acceptance Criteria and Device Performance (Based on Regulatory Compliance)

The acceptance criteria for the Shimadzu "sarano" ultrasound system are implicitly defined by its compliance with recognized industry and regulatory standards for safety and acoustic output. The device "demonstrates" meeting these criteria by stating its adherence to them.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance (as stated in the document)
Electrical Safety	Compliance with IEC 60601-1 (Safety of Medical Electric Equipment)	"The sarano has been designed to meet the following voluntary and measurement standards: IEC 60601-1 Safety of Medical Electric Equipment"
Acoustic Output Measurement and Labeling	Compliance with AIUM NEMA UD2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment) and Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment Revision 1 (AIUM 1998)	"The sarano has been designed to meet the following voluntary and measurement standards: AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment," and "Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment Revision 1 (AIUM 1998)"
Real-time Display of Thermal and Mechanical Acoustic Output Indices	Compliance with AIUM NEMA UD3 (Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment)	"The sarano has been designed to meet the following voluntary and measurement standards: AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment"
Intended Use Equivalence	The device performs diagnostic ultrasound imaging and Doppler analysis for specified clinical applications (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional) in B, M, and combined modes, with various transducers, equivalent to the predicate device.	The Indications for Use statements (pages 5-18) detail the specific clinical applications and operational modes (B, M, (B/M) and N=new indications for Fetal, Abdominal, Small Organ, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal) for the system and each transducer. The 510(k) clearance itself indicates the FDA has determined the device is substantially equivalent to the predicate (Shimadzu Corporation SDU-1100 (K050510)) for these stated indications. Importantly, the FDA letter requests a post-clearance special report containing "acoustic output measurements based on production line devices" to confirm compliance after clearance.

Study Details (Limitations)

The provided document does not describe a clinical study in the traditional sense, with a test set, ground truth, experts, or comparative effectiveness. A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through engineering and performance testing against standards, rather than new clinical effectiveness trials.

Therefore, the following information cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable; no clinical test set for diagnostic performance is described. The "test set" implicitly refers to the device and its components undergoing engineering and safety testing according to the standards listed.
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): Not applicable; no expert-driven ground truth establishment for a diagnostic performance test is described. The "ground truth" here is the adherence to the technical specifications outlined in the referenced standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasound imaging system, not an AI-driven image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is compliance with the technical specifications and safety limits defined by the referenced standards (e.g., IEC 60601-1, AIUM NEMA UD2, AIUM NEMA UD3). This is typically verified through laboratory testing, measurement, and adherence to design controls, not clinical outcomes or expert consensus on diagnostic images from a specific study.
8. The sample size for the training set: Not applicable; this is not an AI/machine learning device requiring a training set for diagnostic classification.
9. How the ground truth for the training set was established: Not applicable.

Summary

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

KD61641

JUL 1 4 2006

510(k) Summary

1.0 SUBMITTER INFORMATION

1.1 Submitter: SHIMADZU MEDICAL SYSTEMS 20101 South Vermont Ave. Torrance, CA 90502-1328 PH: 310-217-8855 FX: 310-217-8869

1.2 Contact: Randal Walker

1.3 Date: March 31, 2006

2.0 DEVICE NAME

2.1 Proprietary Name:	sarano
2.2 Common Name:	Ultrasound Imaging System
2.3 Classification:	Ultrasonic Pulsed Echo Imaging SystemFR # 892.1560, Product Code 90-IYODiagnostic Ultrasound TransducerFR # 892.1570, Product Code 90-ITX
2.4 Predicate Device:	Shimadzu Corporation SDU-1100 (K050510, 4/1/05)

3.0 DEVICE DESCRIPTION

4.0 INTENDED USE

The sarano is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

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

5.0 SAFETY CONSIDERATIONS

The sarano has been designed to meet the following voluntary and measurement standards:

. IEC 60601-1 Safety of Medical Electric Equipment
AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound Equipment
Acoustic Output Measurement and Labeling Standard for Diagnostic . Ultrasound Equipment Revision 1 (AIUM 1998)
AIUM NEMA UD3 Standard for Real-time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

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

Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

JUL 1 4 2006

Mr. Randal Walker National Service Manager Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328

Re: K061641

Trade Name: EchoView/Shimasonic Diagnostic Ultrasound System - sarano 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: Dated: May 12, 2006 Received: June 13, 2006

Dear Mr. Walker:

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 sarano Diagnostic Ultrasound System, as described in your premarket notification:

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

Transducer Model Number

L040-120HU	VA40R-035U	L072-050U
L040-100U	VA57R-0375WU	VA20R-035U
L070-075U	TV11R-055U	VA57R-0375U
VA11R-055U	EC11R-055U
VA13R-035U	UB10R-065U

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, Maryland 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.

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

Page 2 - Mr. Walker

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

Sincerely yours,

David A. Legum

for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

Ultrasound Device Indications Statement

Page _ 1 _ of __ 13

KOGI64 510(k) Number (if known) : Device Name : Diagnostic Ultrasound System sarano, system

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	B	M	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N
Abdominal	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *	N	N	N	N
NeonatalCephalic
Adult Cephalic
Cardiac	N	N	N	N
Transesophageal
Transrectal	N	N	N	N
Transvaginal	N	N	N	N
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N
Laparoscopic
Musculo-skeletalConventional	N	N	N	N
Musculo-skeletalSuperficial	N	N	N	N
Other (Specify)

Mode of Oneration

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

Other Indications or Modes:

Thyroid. Testicles. Breast ** В/М

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Degnan

11 Fridarrating 2

K06641

Prescription Use

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

Ultrasound Device Indications Statement

Page _2 _ of _ 14

K061641 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System sarano. L040-120HU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	B	M	Combined(Specify)**	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *	N	N	N	N
NeonatalCephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N
Laparoscopic
Musculo-skeletalConventional	N	N	N	N
Musculo-skeletalSuperficial	N	N	N	N
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

Thyroid. Testicles. Breast

** B/M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)

Daniel A. Lygonn

val.

K061641

Prescription Use

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

Ultrasound Device Indications Statement

Page _ 3 of _ 14

510(k) Number (if known): K061641.
Device Name: Diagnostic Ultrasound System sarano, L040-100U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	B	M	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ	N	N	N	N
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N
Laparoscopic
Musculo-skeletal	N	N	N	N
Conventional
Musculo-skeletal	N	N	N	N
Superficial
Other (Specify)

Mode of Operation

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

Other Indications or Modes:

LA-AL-A-MILL-A-A-STATE A-1-1-1-1-11-1ISNo. 000E111. 8. 1 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 100110 0014/5/111 1 2 1 1 1 1 1 1ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ146-48-411-4-4-4-80000 -1-41-40-4-4-4	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------I.
A Children Childrenproven and anywood and the first from the control of**. D !!	THE CLAIM OF A BREACH A A B A CHILIN A B A B A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A1Section 4And Acres A Phone A Property A province
with and the may be and the different of the first for the first for the first for	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------THE OWNER OF

LA-AL-A-MILL-A-A-STATE A-1-1-1-1-11-1ISNo. 000E111. 8. 1 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 100110 0014/5/111 1 2 1 1 1 1 1 1ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ146-48-411-4-4-4-80000 -1-41-40-4-4-4

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------I.

A Children Childrenproven and anywood and the first from the control of**. D !!

THE CLAIM OF A BREACH A A B A CHILIN A B A B A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A1Section 4And Acres A Phone A Property A province

with and the may be and the different of the first for the first for the first for

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------THE OWNER OF

David Ch. Leggeem

Abdominal,
K061641

Prescription Else

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

Page ___ of Ultrasound Device Indications Statement

510(k) Number (if known): K061641

910(tr) Name : Diagnostic Ultrasound System sarano. L070-075U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	B	M	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *	N	N	N	N
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N
Laparoscopic
Musculo-skeletalConventional	N	N	N	N
Musculo-skeletalSuperficial	N	N	N	N
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

Thyroid, Testicles, Breast

** B/M

David h. Syomm

Abdominal

K061641

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

Ultrasound Device Indications Statement Page 5 of 14

510(k) Number (if known): K061641.

Device Name : Diagnostic Ultrasound stem sarano. VA11R-055U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	B	M	Combined(Specify)**	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N
Abdominal	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac	N	N	N	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

** B/M

David A. Lepore

Teproductive, Abdominal,

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

Ultrasound Device Indications Statement Page 6 of _14

510(k) Number (if known) : K061641

Device Name : Diagnostic Ultrasound VA13R-035U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	B	M	Combined(Specify)**	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N
Abdominal	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac	N	N	N	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

B/M

David A. Ingram

Reproductive, Abdon

Labels	Values
-------------------------	-------------------------

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

Ultrasound Device Indications Statement

Page _ 7 of _ 14

510(k) Number (if known): `<061641.

Device Name : Diagnostic Ultrasound System sarano. VA40R-035U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

ClinicalApplication	B	M	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N
Abdominal	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

** B/M

... .........

David A. Ingram

ture, Abdominal.

KD61641

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

Ultrasound Device Indications Statement

Page _ 8 of 14

510(k) Number (if known): K061641.
Device Name: Diagnostic Ultrasound System sarano. VA57R-0375WU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

ClinicalApplication	B	M	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N
Abdominal	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Onemation

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

Other Indications or Modes:

**B/M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David the. Seym

of Heproductive, Abdominal,

Devices
KD6164

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

Ultrasound Device Indications Statement Page 9 of 14

510(k) Number (if known) : K061641.

Device Name : Diagnostic Ultrasound System sarano. TV11R-055U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)
Ophthalmic
Fetal		N	N						N	N
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N						N	N
Transvaginal		N	N						N	N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

**B/M

David A. Segram

Abdominal,
K0664

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

Ultrasound Device Indications Statement

Page _ 10_ of _14

510(k) Number (if known) : K061641.

Device Name : Diagnostic Ultrasound System sarano. EC11R-055U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	B	M	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	N	N	N	N
Transvaginal	N	N	N	N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

** B/M

David R. Sycamore

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

Ultrasound Device Indications Statement

Page _ 1 l of 14

510(k) Number (if known): K061641

Device Name : Diagnostic Ultrasound System sarano, UB10R-065U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	B	M	Combined(Specify)**	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)*
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	N	N	N	N
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

**B/M

Daniel A. Degnan

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

Ultrasound Device Indications Statement

Page _12_of _ 14

510(k) Number (if known): K061641

Device Name : Diagnostic Ultrasound System sarano. L072-050U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *		N	N						N	N
NeonatalCephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N						N	N
Laparoscopic
Musculo-skeletalConventional		N	N						N	N
Musculo-skeletalSuperficial
Others (Specify)

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

Other Indications or Modes:

Thyroid. Testicles. Breast ** B/M

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David be degman

Division Sign-Off)
won of Reproductive, Abdominal,
Radiological Devices
510(k) Number K061641

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

Ultrasound Device Indications Statement

Page 13 of _ 14

510(k) Number (if known) : K061641

Device Name : Diagnostic Ultrasound System sarano, VA20R-035U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)
Ophthalmic
Fetal		N	N						N	N
Abdominal		N	N						N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac		N	N						N	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

** B/M

David A. Siyamm

bdominal,
K2061641

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

Ultrasound Device Indications Statement

Page 14 of 14

K061641 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System sarano. VA57R-0375U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

ClinicalApplication	B	M	Combined(Specify)**	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N
Abdominal	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)*
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

B/M

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Leyman

(Division Sign-Off) Division of Reproduc infiniegical Devil 5 : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.