The Acuson P50 ™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

Device Description

The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section.

AI/ML Overview

The provided text is a 510(k) summary for the Siemens Medical Solutions Siemens P50™ Ultrasound System. This document focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies of its own.

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

A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria for the P50 system itself, as it relies on the predicate devices.
Sample size used for the test set and the data provenance: No new clinical test sets are described for performance evaluation.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no new test set is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an ultrasound imaging system, not an AI algorithm in the traditional sense, and its primary function involves human operation.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the context of this 510(k).
How the ground truth for the training set was established: Not applicable.

Explanation of the Device's Approval Approach based on the provided text:

The Siemens P50™ Ultrasound System received 510(k) clearance based on demonstrating substantial equivalence to several legally marketed predicate devices (Teratech Model 2000 Imaging System, Teratech Model 8C4 Endocavity Smart Probe, etc.).

Key arguments for substantial equivalence:

Identicality to predicate devices: "The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section." (Page 2)
Modes of operation: "It is equivalent in modes of operation." (Page 2)
Intended clinical applications: "and intended for the same clinical applications." (Page 2)
Hardware and Software: The hardware and software are explicitly stated as "No change" compared to the Teratech 2000 specified in K051334. (Page 2)
Transducers: The submission details specific transducers intended for use with the ACUSON P50, and their intended uses (clinical application and mode of operation) are largely marked as "P" (previously cleared by FDA) for the various modes (B, M, PWD, CWD, Color Doppler, Combination Modes, and Harmonic Imaging). For the 4V2 Phased Array transducer, K063085 is referenced; for the 7L3 Linear Array, K042055 is referenced; for the 12HL7 Hockeystick Linear Array and 12L5 Linear Array, K051334 is referenced; and for the AuxCW 2MHz Pedof, K063085 is referenced. This indicates that the performance of these transducers for their stated clinical applications has already been established and cleared by the FDA under their respective 510(k) numbers.

In essence, the device meets regulatory requirements by demonstrating that it is as safe and effective as existing legally marketed devices, primarily by being identical or having changes that do not raise new questions of safety or effectiveness. No new, independent performance study validating specific acceptance criteria for the P50 system itself is detailed in this 510(k) summary, as its performance is effectively "inherited" from its predicate devices.

Summary

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K072266
page 1 of 2

AUG 2 9 2007

510(k) Summary Siemens Medical Solutions Siemens P50 ™ Ultrasound System

Siemens Medical Solutions SPONSOR 1. Ultrasound Division 1230 Shorebird Way Mountain View, California
- Sheila W. Pickering Ph.D. Contact Person: Regulatory Affairs

650 943 7187 Telephone:

July 31 2007 Date Prepared:

DEVICE NAME 2.

Proprietary Name:	Acuson P50 ™ Ultrasound System
Common/Usual Name:	Diagnostic Ultrasound System
Classification Name:	Diagnostic Ultrasound Transducer(21 CFR 892.1570, 90-ITX)Ultrasonic Pulsed Echo Imaging System(21 CFR 892.1560, 90-IYO)Diagnostic Ultrasonic Transducer(21 CFR 892.1570, 90-ITX)

PREDICATE DEVICES 3.

K992505	TERATECH Model 2000 Imaging System
K010833	TERATECH Model 8C4 Endocavity Smart Probe
K012191	TERATECH Model 2000 Handheld Ultrasound System with
	Doppler and Harmonic Imaging Modes
K030191	SIEMENS ™ Model 2000/BAS Portable Ultrasound Systems
K040840	TERATECH Model 10V5 Smart Probe
K043278	TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes
K051334	TERASON™ Ultrasound System with Continuous Wave (CW)
	Doppler and add-to-file submissions

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

K072266
Page 2 of 2

Intended Use 4.

DEVICE DESCRIPTION 5.

The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section.

	TERATECH 2000	Acuson P50
Hardware	Specified in K051334	No change
Transducers	Specified in K051334	Increase number oftransducers
Software	Specified in K051334	No change
Labeling	Specified in K051334	Changed only toreflect additionaltransducers

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The Siemens P50 ™ Ultrasound System is substantially equivalent to the Teratech devices listed above which are currently in commercial distribution in the United States. It is equivalent in modes of operation, and intended for the same clinical applications.

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 2 9 2007

Re: K072266

Trade/Device Name: Acuson P50TM Ultrasound System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: August 14, 2007 Received: August 15, 2007

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 ACUSON P50 Ultrasound System, as described in your premarket notification:

Transducer Model Number

4V2 Phased Array	7L3 Linear Array	12HL7 Hockeystick Linear Array
12L5 Linear Array	AuxCW 2MHz Pedof

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.

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

Page 2 - Mr. Mark Job

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 (OS) 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 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 Mr. Paul Hardy at (240) 276-3666.

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

Enclosures

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

Attachment 1

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System:	ACUSON P50 Ultrasound System
Transducer:	(see comments)
	Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation						Other
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb
	Ophthalmic
FetalImaging& Other	Fetal	Nd	N	N	N	Nd	N	Nd
	Abdominal	Nd	N	N	N	Nd	N	Nd
	intra-operative (Spec.)e	Nd	N	N	N	Nd	N	Nd
	Intra-operative (Neuro)	N	N	N	N	N	N	N
	Laparoscopic
	Pediatric	Nd	N	N	N	Nd	N	Nd
	Small Organ (Thyroid,Breast, Testes, etc.)	Nd	N	N	N	Nd	N	Nd
	Neonatal Cephalic	N	N	N	N	N	N	N
	Adult Cephalic	N	N	N	N	N	N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	Nd	N	N	N	Nd	N	Nd
	Musculo-skel. (Superfic)	Nd	N	N	N	Nd	N	Nd
	Intra-luminall	N	N	N	N	Nd	N	N
	Other (Specify)
Cardiac	Cardiac Adult	N	N	Nf	N	Nd	N	N
	Cardiac Pediatric	N	N	Nf	N	Nd	N	N
	Trans-esoph. (Cardiac)	N	N	Nf	N	Nd	N	N
	Other (Specify)
PeripheralVessel	Peripheral vessel	Nd	N	N	N	N	N	Nd
	Other (Specify)

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

" Includes Color Doppler (CD) and (non-directional) Power Doppler.

B+M; B+PWD; B+CWD; B+CD; B+PD;

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles & catheters.

· Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

9 includes Doppler Tissue Imaging (DT)}

Includes uses in milltary field settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Siğn-Off) Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number

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

System:	ACUSON P50 Ultrasound System
Transducer:	4V2 Phased Array (K063085)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation						Other
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	CombModesb
Ophthalmic	Ophthalmic	Pd	P			Pd	P	Pd
	Fetal	Pd	P	P		Pd	P	Pd
	Abdominal	Pd	P	P	P	Pd	P	Pd
	Intra-operative (Spec.)	Pd	P	P	P	Pd	P	Pd
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	Pd	P	P	P	Pd	P	Pd
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic	P	P	P	P	P	P	P
	Adult Cephalic:	P	P	P	P	P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

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

" Includes Color Doppler (CD) and (non-directional) Power Doppler.

8 +M; B+PWD; B+CWD; B+CD; B+PD.

് Harmonic Imaging (HI)

Harmonic infaging (11)
9 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

9 includes Doppler Tissue Imaging (DTI) .

Includes uses in military lieid settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

VPrescription Use (Per 21 CFR 801.109)

Nancy Brogdon

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

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

System:	ACUSON P50 Ultrasound Systems
Transducer:	7L3 Linear Array (K042055)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative (Spec.)a	Pa	P	P		Pa	P	Pa
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)	Pa	P	P		Pa	P	Pa
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	Pa	P	P		Pa	P	Pa
	Musculo-skel. (Superfic)	Pa	P	P		Pa	P	Pa
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel	Pa	P	P		Pa	P	Pa
	Other (Specify)

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

4 Includes Color Doppler (CD) and (non-directional) Power Doppler.

° B+M; B+PWD; B+CWD; B+CD; B+PD.

° Harmonic Imaging (HI)

6 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppier Tissue Imaging (DTI).

& includes Doppler Tissue Imaging (DTI) .

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801. 109)

Nancy C. Brogdon

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

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

System: ACUSON P50 Ultrasound Systems Transducer 12HL7 Hockeystlck Linear Array (K051334) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Clinical Application Other Comb. Specific B દિવેલા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત PWD CWD Color General Dopp® Modes (Track I Only) (Tracks 1 & III) Ophthalmic Ophthalmic Felal Abdominal p P pr P P P Intra-operative (Spec.) P P P P P P Intra-operative (Neuro) Laparoscopic Pediatric Fetal P P a P P ರಿ Small Organ (Thyroid, Imaging & Other Breast, Testes, etc.) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) pa p ﺔ ﺍﻟﻤ P P p Musculo-skel. (Convent.) ਨਾਂ ിച്ച് p Musculo-skel. (Superfic) P P P Intra-luminal Other (Specify) Cardiac Adult Cardiac Pediatric Cardiac Trans-esoph. (Cardiac) Other (Specify) p " ﺔ ﺍﻟﻤ P p Peripheral Peripheral vessel P P Vessel Other (Specify)

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

Includes Color Doppler (CD) and (non-directional) Power Doppler.

B+M; B+PWD; B+CWD; B+CD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

8 includes Doppler Tissue Imaging (DTI) .

Includes uses in military lield settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

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

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

System:Transducer.	ACUSON P50 Ultrasound Systems12L5 Linear Array (K051334)Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
	Ophthalmic
	FetalAbdominalIntra-operative (Spec.)	Pd	P	P		Pd	P	Pd
FetalImaging& Other	Intra-operative (Neuro)LaparoscopicPediatric
	Small Organ (Thyroid,Breast, Testes, etc.)Neonatal Cephalic	Pd	P	P		Pd	P	Pd
	Adult Cephalic
	Trans-rectalTrans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)Musculo-skel. (Convent.)	Pd	P	P		Pd	P	Pd
	Musculo-skel. (Superfic)	Pd	P	P		Pd	P	Pd
	Intra-luminalOther (Specify)
Cardiac	Cardiac Adult
	Cardiac PediatricTrans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel	Pd	P	P		Pd	P	Pd
	Other (Specify)

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

Includes Color Doppler (CD) and (non-directional) Power Doppler.

8 + M; B+PWD; B+CWD; B+CD; B+PD.

° Harmonic Imaging (HI)

I hamments maging ( ... )
4 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

9 includes Doppler Tissue Imaging (DTI) .

Includes uses in military field settings in addition to hospital/clinic settings.

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

Goncurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon
(Division Sign-Off)

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

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

System:	ACUSON P50 Ultrasound Systems
Transducer:	AuxCW 2MHz Pedof (K063085)
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation						Other
General(Track I Only)	Specific(Tracks I & II)	B	M	PWD	CWD	Color Dopp	Comb.Modes
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVascular	Peripheral vessel
	Other (Specify)

ACUSON P50 Ultrasound Systems

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

Includes Color Doppler (CD) and (non-directional) Power Doppler.

8 +M; B+PWD; B+CWD; B+CD; B+PD.

° Harmonic Imaging (Hi)

Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

9 includes Doppler Tissue Imaging (DTI) .

Includes uses in military field settings in addition to hospital/clinic settings.

Includes uses in military (11) :
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Goncurrence of Center for Devices and Radlological Health, Office of Device Evaluation

Prescription Use (Par 21 CFR 801.1 V

Nancy C. Brogdon

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

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.