K Number

Device Name

SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER

Manufacturer

SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI

Date Cleared

2008-12-22

(244 days)

Product Code

IYO ITX IYN

Regulation Number

892.1560

Intended Use

The Modified S2000, the S2000 ABVS Ultrasound System, is intended for the following The Modified Beeral Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, apprications: Contral News Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Supericial Musculoskeletal, and Peripheral Vascular applications. The system supports the Superilean Massantanteretalters for Use tables, including the 14LSBV for Bmode imaging of a patient's breast using an optional automatic scanning function. The device is not intended to be used as a replacement for screening mammography. The system also provides for the measurement of anatomical structures and analysis as provided in the original S2000 Ultrasound System, which provides information that is used by medical heulth care professionals for clinical diagnosis purposes.

Device Description

The Acuson S2000 ABVS Ultrasound System has been designed to meet the following product safety standards: - UL 60601-1, Safety Requirements for Medical Equipment . - I IFC 60601-2-37 Diagnostic Ultrasound Safety Standards - CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment D - AJUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and 이 Mcchanical Acoustic Output Indices on Diagnostic Ultrasound Equipment - AIUM/NEMA UD-2, 1998 Acoustic Output Measurcment Standard for Diagnostic 1 Ultrasound - l 93/42/EEC Medical Devices Directive - Safety and EMC Requirements for Medical Equipment L - . EN/IEC 60601-1 - 8 EN/IEC 60601-1-1 - B EN/IEC 60601-1-2 - IEC 1157 Declaration of Acoustic Power . - . ISO 10993-1 Biocompatibility

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K072786

Reference Devices

K072786

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not mention AI, ML, or any related terms or concepts.

Therapeutic

No
The 'Intended Use / Indications for Use' section states that the system "provides information that is used by medical health care professionals for clinical diagnosis purposes." It does not mention any therapeutic applications.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that the system "provides information that is used by medical healthcare professionals for clinical diagnosis purposes." Additionally, the "Device Description" section lists several safety standards for "Diagnostic Ultrasound Equipment," explicitly identifying it as a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly refers to an "Ultrasound System" and lists hardware safety standards (UL 60601-1, IEC 60601-2-37, etc.), indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the system is for various ultrasound imaging applications (Radiology, Abdominal, Fetal, etc.) and provides measurements and analysis of anatomical structures. This information is used by medical professionals for clinical diagnosis. IVDs, on the other hand, are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state.
Device Description: The description focuses on the physical system, safety standards, and imaging capabilities. There is no mention of analyzing biological samples.
Input Imaging Modality: The input modality is Ultrasound, which is an imaging technique applied directly to the patient, not a method for analyzing in vitro samples.

The device is a diagnostic imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The system also provides for the measurement of anatomical structures and analysis as provided in the original S2000 Ultrasound System, which provides information that is used by medical heulth care professionals for clinical diagnosis purposes.

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

Clinical Application: Ophthalmic, Fetal, Abdominal, Intraoperative (Note 9), Intraoperative Neurological, Pediatric, Small Organ (Note 1), Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Transurethral Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other (specify) Neonatal Cardiac.

Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Specify) BMDC.

Other (Specify): Note 2,3,4,5,7,8,10, 11, 13 (Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric); Note 2,3,4,5,7,8,10, 11,14 (Small Organ, Transrectal, Musculo-skeletal Conventional, Musculo-skeletal Superficial); Note 2,3,4,5,7,8,10 (Neonatal Cephalic, Adult Cephalic); Note 2,3,4,5,6,7,8,10 (Cardiac, Peripheral vessel); Note 2,3,4,5,7,8,10, 11 (Transvaginal); Note 3,4,6 (Neonatal Cardiac).

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 9 For example: vascular, abdominal
Note 10Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear multi-view spatial compounding
Note 13 STIC
Note 14 eSie™ Touch elasticity imaging/FTI

14LSBV Multi-D Array Transducer for use with ACUSON S2000 ABVS

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

Clinical Application: Small Organ (Note 1)
Mode of Operation: B
Other (Specify): Note 2,3,4,5,7,8,10,11,14

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear multi-view spatial compounding
Note 14 eSie™ Touch elasticity imaging/FTI

Product codes

90-IYN, 90-IYC, 90-ITX, IYO

Device Description

The Acuson S2000 ABVS Ultrasound System has been designed to meet the following product safety standards:

UL 60601-1, Safety Requirements for Medical Equipment.
I IFC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment D
AJUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and 이 Mcchanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, 1998 Acoustic Output Measurcment Standard for Diagnostic 1 Ultrasound
l 93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment L
- . EN/IEC 60601-1
- 8 EN/IEC 60601-1-1
- B EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power .
. ISO 10993-1 Biocompatibility

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound imaging

Anatomical Site

Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Central Nervous Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Ophthalmic, Intraoperative, Breast, Testes, Thyroid, Penis, Prostate, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Transurethral Intravascular, Laparoscopic.

Indicated Patient Age Range

Adult, Fetal, Pediatric, Neonatal.

Intended User / Care Setting

Medical healthcare professionals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The S2000 modifications are verified and validated according to the company's design control process.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072786

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

DEC 22 2011

510(k) Summary Prepared August 27, 2008 Revised December 18, 2008

| Sponsor: | Siemens Medical Solutions USA, Inc..
Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 | |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Contact Person: | Sheila W. Pickering Ph.D.
Telephone:
Fax: | (650) 943 7187
(650) 943 7053 |
| Submission Date: | April 18, 2008 | |
| Device Name: | Acuson S2000 ABVS Ultrasound System | |
| Common Name: | Diagnostic Ultrasound System with Accessories | |
| Classification:
Regulatory Class:
Review Category:
Classification Panel: | II
Tier II
Radiology | |

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

A. Legally Marketed Predicate Devices

The Acuson S2000 ABVS Ultrasound system is substantially equivalent to the Acuson S2000 ultrassund system (K072786)and the U-Systems ultrasound system.

B. Device Description:

The Acuson S2000 ABVS Ultrasound System has been designed to meet the following product safety standards:

UL 60601-1, Safety Requirements for Medical Equipment .
I IFC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment D
AJUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and 이 Mcchanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, 1998 Acoustic Output Measurcment Standard for Diagnostic 1 Ultrasound
l 93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment L
- . EN/IEC 60601-1
- 8 EN/IEC 60601-1-1
- B EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power .
. ISO 10993-1 Biocompatibility

C. Intended Use

I). Substantial Equivalence

The submission device is substantially equivalent to the predicate devices with regard to both intended use and technological characteristics.

E. Performance Data

The S2000 modifications are verified and validated according to the company's design control process.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form.

Public Health Service

DEC 16 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Shelly Pearce Regulatory Affairs Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way MOUNTAIN VIEW WAY CA 94043-1344

Re: K081148

Trade/Device Name: Acuson S2000 ABVS 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: November 21, 2008 Received: November 26, 2008

Dear Ms. Pearce:

This letter corrects our substantially equivalent letter of December 22, 2008.

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 Acuson S2000 ABVS Ultrasound System, as described in your premarket notification:

Transducer Model Number

CW2 Probe CW5 Probe EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Array 4P1 Phased Array 6C2 Curved Array 4C1 Curved Arrav 4V1 Phased Array

10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved Array Mechanical 3D 9EVF4 Curved Array V5Ms Multiplane TEE 18L6HD Linear Array 8V3 Phased Array 14L5BV Multi-D Array

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

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

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours,

Jope Mr Why

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

Special 510(k) Notification
Siemens Ultrasound Division
CONFIDENTIAL

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

K081148

Device Name:

ACUSON S2000 ABVS Ultrasound System

Intended Use:

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

	Mode of Operation
Clinical
Application	A	B	M	PWD	CWD	Color
Doppler	Amplitud
e
Doppler	Color
Velocity
Imaging	Combin
ed
(Specify)	Other
(Specify)
Ophthalmic	P	P	P	P	P	P
Fetal		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10, 11,
13
Abdominal		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10, 11,
13
Intraoperative
(Note 9)		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10, 11,
14
Intraoperative
Neurological		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10, 11,
14
Pediatric		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10, 11
Small Organ
(Note 1)		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10,
11,14
Neonatal
Cephalic		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10
Adult Cephalic		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10
Cardiac		P	P	P	P	P	P	BMDC	Note
2,3,4,5,6,7,8,10
Trans-
esophageal		P	P	P	P	P	P	BMDC
Transrectal		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,
11,14
Transvaginal		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10, 11
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note2,3,4,5,6,7,8,
10, 11,14
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10,
11,14

Special 510(k) Notification Siemens Ultrasound Division CONFIDENTIAL

| Musculo-skeletal
Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,
11,14 |
|-------------------------------------|---|---|---|---|---|------|-------------------------------|
| Other (specify)
Neonatal Cardiac | P | P | P | P | P | BMDC | Note 3,4,6 |

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

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 9 For example: vascular, abdominal

Note 10Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear multi-view spatial compounding

Note 13 STIC

Note 14 eSie™ Touch elasticity imaging/FTI

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

Aogui m Why

Prescription Use (Per 21 CFR 801.109) 1

(Division/Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K081148

Special 510(k) Notification Siemens Ultrasound Division CONFIDENTIAL

Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

14LSBV Multi-D Array Transducer for use with ACUSON S2000 ABVS

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

	Mode of Operation
Clinical
Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		N					Note
2,3,4,5,7,8,10,
11, 14
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-
esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Special S10(k) Notification Siemens Ultrasound Division CONFIDENTIAL

Note 8 Power SieScape panoramic imaging Note 10Clarify VE vascular enhancement technology Note 11 Advanced Sieclear multi-view spatial compounding Note 14 eSie™ Touch elasticily imaging/FTI

(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)

Hozan M. Wly
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices, 510(k) Number _