The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

Device Description

The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display. The SC2000™ Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat Panel Display. There is an available off-line workstation (SC2000WP).

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) Summary for the Siemens Acuson SC2000™ Diagnostic Ultrasound System) does not explicitly state quantitative "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and compliance with safety and industry standards.

The "performance data" section primarily highlights the design, verification, and validation processes, and adherence to various safety standards. It does not provide specific metrics like sensitivity, specificity, accuracy, or other performance statistics typically seen in an AI/software device.

Therefore, the table below reflects what can be inferred from the document regarding "acceptance" in the context of a 510(k) submission for a diagnostic ultrasound system:

Acceptance Criteria (Inferred from 510(k) Context)	Reported Device Performance (from document)
Functional Equivalence to Predicate Devices	The SC2000™ Diagnostic Ultrasound System is substantially equivalent to the Acuson Sequoia Plus Ultrasound System (K072365) and other Sequoia™ models (K063085, K051139) with regard to both intended use and technological characteristics.
Safety Compliance	The Acuson SC2000™ has been designed to meet and comply with applicable industry and safety standards, including: UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 1157, and ISO 10993-1.
Intended Use Fulfillment	The system is intended for and performs various applications (Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial) with various imaging modes (2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, Continuous Wave Doppler (CWD)). It also provides measurement and calculation packages.
Verification and Validation Process Adherence	The SC2000™ is "designed, verified, and validated according to the company's design control process and has been subjected to extensive safety and performance testing before release."

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

The document does not explicitly mention a "test set" in the context of clinical performance evaluation (e.g., patient data used to evaluate diagnostic accuracy). The "Performance Data" section describes internal design, verification, and validation testing, and compliance with standards. It does not specify sample sizes for any clinical studies or data sets, nor the provenance (country of origin, retrospective/prospective) of such data.

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

This information is not provided in the document. As there's no mention of a clinical test set with ground truth established by experts, this detail is absent.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, not on comparing the device's performance with and without AI assistance or against human readers.

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

The device is a diagnostic ultrasound system intended for use by a clinician, not a standalone AI algorithm. Therefore, a "standalone algorithm only" performance study, as typically understood for AI/CADe devices, is not applicable and not discussed in this document. The document describes the system providing "information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

7. The Type of Ground Truth Used

The document does not describe the use of ground truth (expert consensus, pathology, outcomes data, etc.) in the context of evaluating diagnostic accuracy or clinical performance for this ultrasound system. The primary "ground truth" implicitly referred to is adherence to established technical specifications and safety standards.

8. The Sample Size for the Training Set

This information is not provided. The document describes a traditional diagnostic ultrasound system, not a machine learning or AI-driven device that would typically have a distinct "training set."

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

This information is not provided, as the device is not presented as an AI/ML system with a training set and associated ground truth establishment process.

Summary

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510(k) SummaryPrepared July 8, 2010			K102017
Sponsor:	Siemens Medical Solutions, Inc.,Ultrasound Division1230 Shorebird WayMountain View, California 94043		SEP 20 2010
Contact Person:	Shelly PearceTelephone:Fax:	(650) 694-5988(650) 694-5580
Submission Date:	July 8, 2010
Device Name:	Acuson SC2000™ Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System
Classification:
Regulatory Class:	II
Review Category:	Tier II

Category: Classification Panel: Radiology

Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYO
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX

A. Legally Marketed Predicate Devices

The Acuson SC2000™ Ultrasound System is substantially equivalent to the Acuson Sequoia Plus Ultrasound System, K072365..

B. Device Description:

The SC2000™ Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat Panel Display. There is an available off-line workstation (SC2000WP)

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C. Intended Use

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy from either a transmoracic or transesophageal approach in adult and pediatric patients; and from a transthoracic approach in neonatal and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The svstem may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide quidance during neurological intraoperative procedures.

Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.

The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

D. Substantial Equivalence

The submission device is substantially equivalent to the predicate Acuson Sequoia™ previously cleared under K063085 and K051139 and the Sequoia™ Plus Diagnostic Ultrasound System previously cleared under K072365 with regard to both intended use and technological characteristics.

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E. Performance Data

The SC2000™is designed, verified, and validated according to the company's design control process and has been subjected to extensive safety and performance testing before release. Final testing of the SC2000 included various safety and performance testing designed to ensure the device meets all of its specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards including:

The Acuson SC2000™ has been designed to meet the following product safety standards:

트 UL 60601-1, Safety Requirements for Medical Equipment
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
. AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
사 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
포 Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1 .
- . EN/IEC 60601-1-1
- . EN/IEC 60601-1-2
I IEC 1157 Declaration of Acoustic Power
I ISO 10993-1 Biocompatibility

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

Siemens Medical Solutions USA, Inc., . % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

SEP 2 0 2010

Re: K102017

Trade/Device Name: SC2000TM Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 26, 2010 Received: August 27, 2010

Dear Mr. Job:

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 SC2000™ Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

91.4 V5M TEE 4V1c

8V3c AUX CW2 4Zlc (Apollo)

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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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

If you have any questions regarding the content of this letter, please contact Ewa Czerska at (301) 796-6541.

Sincerely yours,

Donald St. Pierre

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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1.3 Indications for Use

510(k) Number (if known):

Device Name:

SC2000™Diagnostic Ultrasound System

SEP 2 0 2010

Indications for Use:

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neonatal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy from either a transthoracic or transesophageal approach in adult and pediatric patients; and from a transthoracic approach in neonatal and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological intraoperative procedures.

(Division Sign-Off)
Division of Radiological Devices

SC2000 510(k) Submission

Office of In Vitro Diagnostic Device Evaluation and Safety

K162117

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Transcranial Imaging Applications

The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)

S
(Division Sign-Off)

Division of Rediological De Division of Redictor of Redictorios Co.
Office of In Vitro Diagnostic Device Evalue

K102017
510K

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1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

SC2000 Diagnostic Ultrasound System Device Name:

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

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging	Other:3D	Other:RealTime3D
Ophthalmic
Fetal	N	N	N	N	N	N		N*	N	N	N
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological	P	P	P		P	P	P		P*	P
Pediatric	P	P	P	P	P	P	P		P*	P	P	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic	P	P	P	P	P	P	P		P*	P
Cardiac	P	P	P	P	P	P	P		P*	P	P	P
Trans-esophageal	P	P	P	P	P				P*		P
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel	P	P	P		P	P	P		P*	P
Laparoscopic
Musculo-skeletalConventional	P	P	P		P	P	P		P*	P
Musculo-skeletalSuperficial	P	P	P		P	P	P		P*	P
Other (specify) **	P	P	P	P	P	P	P		P**	P

N=new indication. P = Previously Cleared in 510(k) K063085; K072365; K051139

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

**neonatal cardiac
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	Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)
	Prescription Use (Per 21 CFR 801.109)
SC2000 510(k) Submission	(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety	Page 15 of 39

510K.

K102017

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510(k) Number (if known):

Device Name:

9L4

Indications for Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

ClinicalApplication	B	M	PWD	CWD	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological	P	P	P	P	P	P	P	P*	P
Pediatric
Small Organ **(specify)
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel	P	P	P	P	P	P	P	P*	P
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	P	P*	P
Musculo-skeletalSuperficial	P	P	P	P	P	P	P	P*	P
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K063085; K072365 Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color

Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

$100

AAR

SC2000 510(k) Submission

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

Page 16 of 39

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510(k) Number (if known):

Device Name:

V5M TEE

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:3D
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P*	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P*	P
Trans-esophageal	P	P	P	P	P	P	P*	P
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K063085; K072365 Additional Comments:

*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

510K

signature

SC2000 510(k) Submission

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510(k) Number (if known):

Device Name:

4V1c

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P	P *	P
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P *	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic	P	P	P	P	P	P	P	P *	P
Cardiac	P	P	P	P	P	P	P	P *	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other(specify)***	P	P	P	P	P	P	P	P *	P

N=new indication. Previously Cleared in 510(k) K063085; K072365

Additional Comments:

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510K

signature

SC2000 510(k) Submission

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

510(k) Number (if known):

Device Name:

8V3c

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P*	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other(specify)***	P	P	P	P	P	P	P*	P

N=new indication. Previously Cleared in 510(k) K063085; K072365

Additional Comments:

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

s.s.s

BIOK

SC2000 510(k) Submission

(Division Sign-Off Division of Radiological Devic Office of In Vitro Olagnostic aluation and Safety

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510(k) Number (if known):

Device Name:

AUX CW2

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric					P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel					P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. Previously Cleared in 510(k) K072365; K063085; K001400

Additional Comments:

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

A. Dt. A.

SC2000 510(k) Submission

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

$10K IC02017

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510(k) Number (if known):

Device Name:

4Z1c (Apollo)

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:HarmonicImaging	Other:RealTime3D
Ophthalmic
Fetal	P	P	P	P	P	P*	P	P
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P*	P	P
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P*	P	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other(specify)***

N=new indication. P = Previously Cleared in 510(k) K072365; K051139

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

DLR

510K

SC2000 510(k) Submission

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

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.