K Number

Device Name

IU22 ULTRASOUND SYSTEM AND TRANSDUCERS

Manufacturer

PHILIPS ULTRASOUND, INC.

Date Cleared

2010-02-01

(75 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

The iU22 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, Harmonics (Tissue and Contrast) and Elastography modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small Organ Adult and Neonatal Cephalic Trans-rectal Trans-vaginal Musculoskeletal Urology Cardiac (Adult, Pediatric, Trans-esophageal) Fetal Echo Peripheral Vessel The clinical environments where the iU22 3.7 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.

Device Description

The subject of this 510(k) notification, the iU22 ultrasound 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 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 healthcare 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

K042540, K072786, K021966, K023877

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional ultrasound technology.

Therapeutic

No.
The device is strictly for diagnostic purposes, as indicated by its "Intended Use / Indications for Use" section stating "intended for diagnostic ultrasound imaging" and "make a diagnosis". It does not mention any therapeutic functions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The iU22 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging..." and "It is indicated for diagnostic ultrasound imaging and fluid flow analysis..."

SaMD (Software as a Medical Device)

The device description explicitly states that the device includes both the iU22 ultrasound system and transducer(s), which are hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The iU22 Diagnostic Ultrasound System uses ultrasound waves to create images of internal body structures and analyze fluid flow within the body. It does not analyze samples taken from the body.
Intended Use: The intended use describes diagnostic ultrasound imaging and fluid flow analysis in vivo (within the living body) for various anatomical sites.
Device Description: The description details how the system generates and transmits ultrasound waves into the body and processes the echoes.

Therefore, the iU22 Diagnostic Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The iU22 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, Harmonics (Tissue and Contrast) and Elastography modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small Organ Adult and Neonatal Cephalic Trans-rectal Trans-vaginal Musculoskeletal Urology Cardiac (Adult, Pediatric, Trans-esophageal) Fetal Echo Peripheral Vessel

The clinical environments where the iU22 3.7 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.

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

90IYN, 90IYO, 90ITX

Device Description

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

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Intra-operative, Abdominal, Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicle), Adult and Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal, Urology, Cardiac (Adult, Pediatric, Trans-esophageal), Fetal Echo, Peripheral Vessel, Cerebral Vascular

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Competent healthcare professionals in point-of-care areas in offices, clinical and hospital settings.

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.

K042540, K072786, K021966, K023877

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

§ 892.1550 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.

Summary

510(k) Premarket Notification

FEB - 1 2010 510(k) Summary of Safety and Effectiveness iU22 Diagnostic Ultrasound System

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, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431

Contact person: Nancy Burke, Regulatory Affairs Specialist Email: Nancy.Burke@philips.com Tel: (425) 487-7371 Fax: (425) 487-8666

Date prepared: November 3, 2009

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 and transducers Proprietary name: iU22 Ultrasound System

These devices are classified as follows:

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

As stated in 21 CFR, parts 892.1550, 892.1560 and 892.1570, each of these generic types of devices have been classified as Class II.

3. Substantially Equivalent Devices

Philips Ultrasound believes that the iU22 Ultrasound System is substantially equivalent to the following currently marketed devices:

Product	510(k)
Philips iU22	K042540
Siemens Acuson S2000	K072786
Philips QLAB	K021966, K023877

4. Device Description and 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 healthcare professionals to make a diagnosis.

5. Intended Use

Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small Organ Adult and Neonatal Cephalic Trans-rectal Trans-vaginal Musculoskeletal Urology Cardiac (Adult, Pediatric, Trans-esophageal) Fetal Echo Peripheral Vessel

The clinical environments where the iU22 3.7 system can be used include point-ofcare areas in offices, clinical and hospital settings for diagnosis of patients.

6. Conclusion

iU22 Ultrasound System and transducers is substantially equivalent in safety and effectiveness to the predicate devices identified above:

The systems are indicated for the diagnostic ultrasonic imaging and fluid flow ♥ analysis.
The systems have the same gray-scale and Doppler capabilities. .
The systems have acoustic output levels below the Track 3 FDA limits. .
The systems are manufactured under equivalent quality systems. .
The systems are manufactured of materials with equivalent biosafety. The . materials have been evaluated and found to be safe for this application.
The systems are designed and manufactured to the same electrical and physical . safety standards.

Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three birds in flight, arranged in a vertical stack. The birds are silhouetted and appear to be soaring upwards.

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

FEB - 1 2010

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K093563

Trade/Device Name: iU22 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: January 12, 2010 Received: January 13, 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 iU22 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

L12-5

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.

Page 2 - Mr. 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 (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/RevortaProblem/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

signature

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)

Philips Ultrasound, Inc. 510(k) Premarket Notification

510(k) Number (if known):

Device Name: iU22 Diagnostic Ultrasound System

Indications for Use:

Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small Organ Adult and Neonatal Cephalic Trans-rectal Trans-vaginal Musculoskeletal Urology Cardiac (Adult, Pediatric, Trans-esophageal) Fetal Echo Peripheral Vessel

The clinical environments where the iU22 3.7 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.

Prescription Use XX (Part 21 CFR 801 Subpart D) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amel J. R.

(Division Sign Off) Division of Radiological Devices

510(k) Number	K093563
---------------	---------

Indications for Use Statement

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No: System: Intended Use:

iU22 Ultrasound System

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	P	P	P		P	Notes 1,3	Notes, 5,6,8,10,12,13
Fetal Imaging
& Other	Fetal (includes Echo)	P	P	P		P	Notes 1,2,3	Notes,
5,6,7,8,10,11,12,13
	Abdominal (includes urology)	P	P	P		P	Notes 1,2,3	Notes,
5,6,7,8,9,10,11,12,13
	Intra-operative
(Abdominal, cardiac, spine, Vascular)	P	P	P	E*	P	Notes
1,2,3,4	Notes 5,6,8,10,12,13
	Intra-operative (Neuro.)	P	P	P		P	Notes 1, 3	Notes 3,5,6,10,12,13
	Laparoscopic	P	P	P		P	Notes 1, 3	Notes 8,10,12,13
	Pediatric	P	P	P	E*	P	Notes 1,2, 3	Notes 5,6,8,9,10,12,
13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Notes 1,2, 3	Notes
5,6,8,9,10,11,12,13,15
	Neonatal Cephalic	P	P	P		P	Notes 1,3	Notes 5,8,10,12,13
	Adult Cephalic	P	P	P		P	Notes 1,3,4	Notes 10, 13
	Trans-rectal	P	P	P		P	Notes 1,3	Notes 5,6,10,11,12, 13
	Trans-vaginal	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	Notes 1,2,3	Notes 5,6,8,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Notes 1,2,3	Notes 5,6,8,10,12,13
	Intra-luminal
	Other: Urology	P	P	P		P	Notes 1,3	Notes 5,6,10,12
Cardiac	Cardiac Adult	P	P	P	P	P	Notes
1,2,3,4	Notes 10,11,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Notes
1,2,3,4	Notes 10,11,12,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Notes
1,2,3,4	Notes 10,11,12,13
	Other (Fetal Echo)	P	P	P	P	P	Notes
1,2,3,4	Notes 5,10,12,13
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Notes
1,2,3,4	Notes
2,3,5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P		P	Notes 1, 2, 3	Notes 5,6,8,9,10,12,13

N= new indication; P= previously cleared (K042540); E= added under Appendix E (*9/21/2005)

Additional Comments:
*Color Doppler includes Color Amplitude Doppler	Note 8: Extended Field of View (EFOV), AKA Panoramic
Imaging includes SonoCT imaging
Note 1: Combined modes include: B+PWD; B+Color;
B+Amplitude; B+M	Note 9: EFOV including Amplitude Doppler
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 12: 3D Imaging
Note 5: SonoCT	Note 13: XRES
Note 6: Imaging for guidance of biopsy	Note 14: TDI
Note 7: Infertility monitoring of follicle development	Note 15: Elastography

DHR

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

(Division Sign-Off) Division of Radiological Devices

510(k) Number K093563

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No:
System:
Transducer:
Intended Use:

iU22 Ultrasound System

12-5

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General	Specific	в	M	PWD	CWD	Colar	Combined*	Other
(Track I only)	(Tracks & III)					Doppler*	(Spec.)	(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)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	p		P	Notes 1, 3	Notes 5,6,8,10,12,13
	Small Organ (Breast, thyroid,	P	P	ר		p	Notes 1, 3	Notes
	testicle)							5,6,8,10,11,12,13,15
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Notes 1, 2, 3	Notes 5,6,8,10,12,13
	Musculo-skel. (Superficial)	D	P	P		P	Notes 1, 2, 3	Notes 5,6,8,10,12,13
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Fetal Echo
Perpheral	Peripheral vessel	p	P	0		P	Notes 1, 2, 3	Notes 5,6,8,9,10,12,13
Vessel	Cerebral Vascular	P	P	്		p	Notes 1, 2, 3	Notes 5,6,8,9,10,12,13

N= new indication; P= previously cleared (K030455), E= Added under appendix E.

Additional Comments:

| *Color Doppler includes Color Amplitude Doppler | Note 8: Extended Field of View (EFOV), AKA Panoramic
Imaging includes SonoCT imaging | | | | |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--|--|--|--|
| Note 1: Combined modes include: B+PWD; B+Color;
B+Amplitude; B+M | Note 9: EFOV including Amplitude Doppler | | | | |
| Note 2: Combined modes include: B+M+Color | Note 10: Harmonic Imaging | | | | |
| Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD | Note 11: Contrast Imaging | | | | |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD | Note 12: 3D Imaging | | | | |
| Note 5: SonoCT | Note 13: XRES | | | | |
| Note 6: Imaging for guidance of biopsy | Note 14: TDI | | | | |
| Note 7: Infertility monitoring of follicle development | Note 15: Elastography | | | | |

signature

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

(Division Sign-Off) Division of Radiological Devices

510(k) Number K093563