K Number

Device Name

PHILIPS IU22 ULTRASOUND SYSTEM

Manufacturer

PHILIPS ULTRASOUND, INC.

Date Cleared

2004-10-04

(14 days)

Product Code

IYO ITX IYN

Regulation Number

892.1560

Intended Use

The iU22 system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body.

Device Description

The iU22 system and transducer(s) function in a manner identical to all diagnostic ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow. The iU22 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

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

K040227, K022824, K022303

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ultrasound technology and signal processing, with no mention of AI or ML.

Therapeutic

No
The device is described as being intended for diagnostic ultrasound imaging and fluid flow analysis, and its function relates to generating images and providing information for diagnosis, not for treating conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system and transducers are "intended for diagnostic ultrasound imaging and fluid flow analysis of the human body." Furthermore, the "Device Description" mentions that the system "offers analysis packages that provide information used by competent health care professionals to make a diagnosis."

SaMD (Software as a Medical Device)

The device description explicitly mentions hardware components like "system circuitry," "transducer," and "piezo electric array," which are integral to its function and are not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is "diagnostic ultrasound imaging and fluid flow analysis of the human body." This describes a device that interacts directly with the patient's body to produce images and analyze physiological processes in vivo.
Device Description: The description details how the system generates and transmits ultrasonic waves into the body and receives echoes. It also explains the Doppler function for analyzing blood flow within the body.
Mechanism of Action: The device works by sending and receiving ultrasound waves through body tissues, not by analyzing samples taken from the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates by imaging and analyzing processes within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The iU22 system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body.

iU22 Ultrasound imaging or fluid flow analysis of the human body as follows:

Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal, Cardiac*, Spine, Vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicle)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other: Urology
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (Fetal Echo)
Peripheral vessel
Cerebral Vascular

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX

Device Description

The iU22 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Human body, Ophthalmic, Fetal, Abdominal, Cardiac, Spine, Vascular, Neuro, Pediatric, breast, thyroid, testicle, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph., Musculo-skeletal, Intra-luminal, Peripheral vessel, Cerebral Vascular.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Competent health care 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)

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K040227, K022824, K022303

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

K04254D

OC7 4 - 2004

510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92.

1) Submitter's name, address, telephone number, contact person

Philips Ultrasound 22100 Bothell Everett Highway Telephone: (425) 487-7312 Facsimile: (425) 487-8666 E-mail: Lynn.harmer@philips.com

Contact Person: Lynn Harmer

Date prepared: 21 July 2004

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name:	Diagnostic ultrasound system with accessories
Proprietary Name:	iU22 ultrasound system

Classification Name	21 CFR Section	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasonic Transducer	892.1570	90-ITX

3) Substantially Equivalent Devices

Philips Ultrasound believes that the iU22 system and transducers are substantially equivalent to the following currently marketed devices:

QLAB (K040227;) LV Analysis (K022824;) and M2424 (K022303)

4) Device Description & Technical Comparison to Predicate Devices

The iU22 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

5) Intended Use

The iU22 system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body.

6) Conclusion

The iU22 system and transducers are substantially equivalent in safety and effectiveness to the predicate systems and transducers listed in item 3 above.

. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis.
The systems have the same gray-scale and Doppler capabilities. .
The systems use essentially the same technologies for imaging, Doppler functions and . signal processing.
. The systems have acoustic output levels below the applicable FDA limits.
The systems are manufactured of materials with materials that have been evaluated . and found to be safe for its application.
. The systems are designed and manufactured to applicable electrical and physical safety standards.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 4 - 2004

Phillips Ultrasound, Inc. % Ms. Michelle S. Lee Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K042540

ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

Trade Name: iU22 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: September 17, 2004 Received: September 20, 2004

Dear Ms. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w onate formed your booms been 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 May 20, 1910, and vith 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 iU22 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

X3-1 दर्श्-रि

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

· Page 2 - Ms. Lee

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours.

Daniela Logemann

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

Enclosure(s)

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System:

iU22 Ultrasound System

Intended Use:

1022 Untrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler**	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	P	P	P	P	P	Notes 1, 3	Notes 5, 6, 8,10,12, 13
	Fetal	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 7, 8, 10, 12, 13
	Abdominal	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 7, 8, 10, 11, 12, 13
	Intra-operative
(Abdominal, Cardiac*, Spine, Vascular)	P/N*	P/N*	P/N*	P/N*	P/N*	Notes 1, 3	Notes 5, 6, 8,10,12, 13
Fetal Imaging
& Other	Intra-operative (Neuro.)	P	P	P	P	P	Notes 1, 3	Notes 3, 5, 6, 10, 12, 13
	Laparoscopic	P	P	P	P	P	Notes 1, 3	Notes 8, 10, 12, 13
	Pediatric	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8, 9, 10, 12, 13
	Small Organ (breast, thyroid, testicle)	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8, 10, 11, 12, 13
	Neonatal Cephalic	P	P	P	P	P	Notes 1, 3	Notes 5, 8, 10, 12, 13
	Adult Cephalic	P	P	P	P	P	Notes 1, 3, 4	Notes 10, 13
	Trans-rectal	P	P	P	P	P	Notes 1, 3	Notes 5,6,10,11,12, 13
	Trans-vaginal	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 7,10, 11,12, 13
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8,10, 12,13
	Musculo-skel. (Superficial)	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8, 10, 12,13
	Intra-luminal
	Other: Urology	P	P	P	P	P	Notes 1, 3	Notes 5, 10, 12
Cardiac	Cardiac Adult	P	P	P	P	P	Notes 1,2,3,4	Notes 10, 11, 12, 13
	Cardiac Pediatric	P	P	P	P	P	Notes 1,2,3,4	Notes 10, 11, 12, 13
	Trans-esophageal (Cardiac)	P	P	P	P	P	Notes 1,2,3,4	Note 10
	Other (Fetal Echo)	P	P	P	P	P	Notes 1,2,3,4	Notes 5,10, 12, 13
Peripheral	Peripheral vessel	P	P	P	P	P	Notes 1, 2, 3	Notes 2, 3, 5, 6, 7, 8, 10, 12, 13
	Cerebral Vascular	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8, 10, 12, 13

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

Additional Comments:

*Addition of intraoperative (cardiac)

**Color Doppler includes Color Amplitude Doppler

Oolor Doppior instados Solor Include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 2: Combined modes include: B+Color+PWD; B+Amplitude+PWD;
Note 3: Combined modes include: B+Color+PWD; B+Amplit

Note of Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 7. Internity monitoring of follore development
Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Prescription Use (Per 21 CRF 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Lyons

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devic 510(k) Number _

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System: Transducer: Intended Use:

iU22 Ultrasound System

X3-1 XS-1
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	Notes 1, 3	Notes 5, 6, 8, 10,
12, 13
	Abdominal	P	P	P		P	Notes 1,3	Notes 5, 6, 8, 10,
12, 13
	Intra-operative (cardiac)	N	N	N		N	Notes 1,2,3	Notes 10, 11, 12, 13
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
	Cardiac Adult	N	N	N	N	N	Note 1	Notes 10, 11, 12, 13
Cardiac	Cardiac Pediatric	N	N	N	N	N	Notes 1, 2, 3	Notes 10, 11, 12, 13
	Trans-esophageal (Cardiac)					P
	Fetal Echo	P	P	P		P	Notes 1, 2, 3	Notes 5, 10, 12,13
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

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

Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Oolor Doppior Inoladoo Ocieclude: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 2: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 7. Internity monitoring of follors and of others.
Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 12: YPES

Note 13: XRES

Prescription Use (Per 21 CRF 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Syson

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

Section 4.3

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number:
System:
Transducer:
Intended Use:

iU22 Ultrasound System

$5-1 53-1
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
Abdominal
Intra-operative (cardiac)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
	Other (Specify)
Cardiac Adult	E	E	E	E	E	Notes 1, 2 3,
4	Notes 10, 11, 13
Cardiac	Cardiac Pediatric	E	E	E	E	E	Notes 1, 2 3,
4	Notes 10, 11, 13
	Trans-esophageal (Cardiac)
Fetal Echo
Peripheral
Vessel	Peripheral vessel
Cerebral Vascular

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

Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Solor Dopping modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 2: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note e: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 7. Infentify monitoring of follors devolusions
Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 12, OD Rings
Note 13, YDES

Note 13: XRES

Prescription Use (Per 21 CRF 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radining cal Devices 51(%) Number