K Number

Device Name

HD7 DIAGNOSTIC ULTRASOUND SYSTEM

Manufacturer

PHILLIPS MEDICAL SYSTEMS

Date Cleared

2008-03-27

(28 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows: Ophthalmic, Fetal/Obstetric, Abdominal, Intra-operative (vascular/epicardial), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Other (Gynecological), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Fetal), Peripheral vessel, Musculo-skel (conventional), Musculo-skel (superficial).

Device Description

The HD7 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate 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 differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the 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.

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

K014191

Reference Devices

K043535, K991671, K961459

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 a "diagnostic ultrasound device" and its intended use is for "Diagnostic ultrasound imaging and fluid flow analysis of the human body," indicating it is used for diagnosis rather than treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging and fluid flow analysis of the human body." Additionally, the "Device Description" section begins by stating, "The HD7 is a diagnostic ultrasound device."

SaMD (Software as a Medical Device)

The device description explicitly states it consists of a system console, display screen, and transducers, 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 Description: The description clearly states that the device is a "diagnostic ultrasound device" that uses ultrasonic pressure waves transmitted through body tissues to create images. It does not involve analyzing samples taken from the body.
Intended Use: The intended use describes imaging and fluid flow analysis of the human body, not analysis of samples from the human body.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body

Product codes

90IYN, 90IYO, 90ITX

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Ophthalmic, Fetal/Obstetric, Abdominal, Intra-operative (vascular/epicardial), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Gynecological, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Fetal, Peripheral vessel, Musculo-skel (conventional), Musculo-skel (superficial)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

K014191

Reference Device(s)

K043535, K991671, K961459

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

2080548
MAR 27 2008

Summary of Safety and Effectiveness 3.2

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 as implemented in 21 C.F.R. $807.92.

The submitter of this premarket notification is:

Nancy P. Burke Regulatory Specialist Philips Medical Systems 22100 Bothell Everett Highway Bothell, WA 98021-8431 Tel: (425) 487-7371 Fax: (425) 487-8666

This summary was prepared on February 15, 2008.

The proprietary name of the device is the HD7 Diagnostic Ultrasound System. In combination with transducers - L12-3, L12-5 50, 15-6L, S4-2, S8, C5-2, C6-3, C8-5, D5009V, E6509, C8-4V, T6H- are commonly known as a diagnostic ultrasound system and transducers.

These devices are classified as follows:

90IYN	Ultrasonic Pulsed Doppler Imaging System
90IYO	Ultrasonic Pulsed Echo Imaging System
90ITX	Diagnostic Ultrasound Transducer

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.

The HD7 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. It is substantially equivalent to the currently marketed M2540/EnVisor ultrasound systems and transducers cleared in K014191.

The HD7 system and transducers function in a manner identical to all Philips 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 differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the 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 HD7 is intended for diagnostic ultrasound imaging and fluid flow analysis.

The HD7 is substantially equivalent in safety and effectiveness to the predicates identified above:

Both the predicate device and the HD7 are indicated for the diagnostic ultrasonic imaging . and fluid flow analysis.
Both the predicate device and the HD7 have the same gray-scale and Doppler . capabilities.
. Both the predicate device and the HD7 use essentially the same technologies for imaging. Doppler functions and signal processing.
Both the predicate device and the HD7 have acoustic output levels below the Track 3 . FDA limits.
Both the predicate device and the HD7 are manufactured under equivalent quality . systems.
Both the predicate device and the HD7 are manufactured of materials with equivalent . biosafety. The materials have been evaluated and found to be safe for this application.
. Both the predicate device and HD7 are designed and manufactured to the same electrical and physical safety standards.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2008

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

Re: K080548

Trade/Device Name: HD7 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: March 13, 2008 Received: March 14, 2008

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 HD7 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

21422A (S4-2) 21350A (S8) 21475A (L12-3) 989803002251 (L12-5 50)

21390A (15-6L) 21426A (C5-2) 989605352341 (C8-5) 989803002683 (C8-4v) 21336A (E6509) 989605359591 (C6-3) 21223B (D5009V) 21378A (T6H)

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 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 (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/cdrb/industry/support/index.html

Page 3 – Mr. Mark Job

If you have any questions regarding the content of this letter, please contact Ms. Lauren Hefner at (240) 276-3666.

Sincerely yours,

Arge M. Mather

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

Enclosure(s)

4.3.2 Indications for Use Tables

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number: Device name: HD7 Diagnostic Ultrasound System 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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic	N	N	N	N	N	N	N
	Fetal/Obstetric	N	N	N	N	N	N	N
	Abdominal	N	N	N	N	N	N	N
	Intra-operative
(vascular/epicardial)	N	N	N	N	N	N	N
	Intra-operative (Neuro)	N	N	N		N	N	N
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	N	N	N	N	N	N	N
	Small Organ (thyroid, scrotum,
prostate, breast)	N	N	N		N	N	N
	Neonatal Cephalic	N	N	N		N	N	N
	Adult Cephalic	N	N	N	N	N	N	N
	Trans-rectal	N	N	N		N	N	N
	Trans-vaginal	N	N	N		N	N	N
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)	N	N	N	N	N	N	N
	Cardiac Adult	N	N	N	N	N	N	N
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	N
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N
	Other (Fetal)	N	N	N		N	N	N

Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	N	N
	Other (Specify)
	Musculo-skel (conventional)	N	N	N		N	N	N
	Musculo-skel (superficial)	N	N	N		N	N	N
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other modes: Color Power Angio, 3-D Imaging, Panoramic, Harmonics (Tissue & Contrast), , Directional Angio Imaging, Tissue Doppler Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: No previous 510(k)s are associated with this product

Previous Submission: No previous stocks are associated with this product.

(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)

(Division Sign-O Division of Reproductive, Abdom and Radiological Dev 510(k) Number

| | Clinical Application (Track I
Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(Specify) |
|--|-------------------------------------------------------------------------------------------------------------------------| | | Ophthalmic | | | Fetal
Imaging
& Other | | | | | | | (vascular/epicardial) | | | | | | | |
| | | | | | | | | | | | prostate, breast) | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Peripheral
Vessel | | | | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | *Other modes include: Color Power Angio, 3D, Panoramic, Harmonics, Directional Angio Imaging, Tissue
Doppler Imaging | | | | | | | | General
------------------------------|-----------------------------------------------------|---|---|-----|-----|------------------|-----------------------|---------------------|
| Ophthalmic | P | | P | P | P | P | P |
| Fetal/Obstetric | P | P | P | P | P | P | P |
| Abdominal | P | P | P | P | P | P | P |
| Intra-operative
| Intra-operative (Neuro) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | P | P | P | P |
| Small Organ (thyroid, scrotum,
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (Gynecological) | P | P | P | P | P | P | P |
| Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esoph. (Cardiac) | | | | | | | |
| Other (Fetal) | | | | | | | |
| Peripheral vessel | E | E | E | E | E | E | E |
| Other (Specify) | | | | | | | |
| Musculo-skel (conventional) | | | | | | | |
| Musculo-skel (superficial) | | | | | | | |
| | | | | | | | |
| | |

Combined modes:. Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: K014191 for Ophthalmic, Fetal, Abdominal, Pediatric, Adult Cephalic, Adult &

Pediatric Cardiac. K043535 for Gynecological, Peripheral Vessel.

(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)

Horyn Th Wh
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic

510(k) Number.

Clinical Application		Mode of Operation
General
(Track I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative
(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P	P	P	P
	Small Organ (thyroid, scrotum,
prostate, breast)
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)	P	P	P	P	P	P	P
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esoph. (Cardiac)
	Other (Fetal)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (Specify)
	Musculo-skel (conventional)
	Musculo-skel (superficial)

(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)

hro Th Wh

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

510(k) Number _

510(k) Number:	System: HD7 Diagnostic Ultrasound System
Transducer:	21475A (L12-3) Linear ArrayTransducer
	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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal	P	P	P		P	P	P
	Intra-operative
(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P
	Small Organ (thyroid, scrotum,
prostate, breast)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Fetal)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (Specify)
	Musculo-skel (conventional)	P	P	P		P	P	P
	Musculo-skel (superficial)	P	P	P		P	P	P
	N= new indication; P= previously cleared by FDA; E= added under Appendix E
	*Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio
Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: K014191

(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)

Anya M. Whig

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices

510(k) Number

510(k) Number:

System: HD7 Diagnostic Ultrasound System

Transducer: 989803002251 (L12-5 50) Linear Transducer

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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal	E	E	E		E	E	E
	Intra-operative
(vascular/epicardial)	E	E	E		E	E	E
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P
	Small Organ (thyroid, scrotum,
prostate, breast)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Fetal)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (Specify)
	Musculo-skel (conventional)	P	P	P		P	P	P
	Musculo-skel (superficial)	P	P	P		P	P	P

*Other modes: Color Power Angio, Panoramic, Directional Angio Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color

Previous submission: K991671 for Intraoperative (Abdominal and Vascular Small Parts,) Musculo-skeletal (conventional and Superficial), Pediatric, Peripheral Vascular

(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)

Homer In White

(Division Sign-Off) Division of Reproductive, Abdom

Radiological Devices
510(k) Number K080548

510(k) Number:
	System: HD7 Diagnostic Ultrasound System
Transducer:	21390A (15-6L) Linear array transducer
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application						Mode of Operation
General	Specific	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
(Track I
Only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal
	Intra-operative
(vascular/epicardial)	P	P	P		P	P	P
	Intra-operative (Neuro)	P	P	P		P	P	P
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P		P
	Small Organ (thyroid, scrotum,
prostate, breast)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Fetal)
Peripheral
Vessel	Peripheral vessel	P	P	P		P
	Other (Specify)						P	P
	Musculo-skel (conventional)	P	P	P		P	P	P
	Musculo-skel (superficial)							P
	N= new indication; P= previously cleared by FDA; E= added under Appendix E
	*Other modes: Amplitude Doppler, Panoramic, Directional Angio Imaging
	Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
	Previous submission: K014191

(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)

Lozano, Jr.

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

510(k) Number_

Clinical Application						Mode of Operation
General
(Track I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative
(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P
	Small Organ (thyroid, scrotum,
prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)	P	P	P		P	P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Fetal)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (Specify)
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	N= new indication; P= previously cleared by FDA; E= added under Appendix E
	*Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio
	Imaging, iSCAN, Doppler/2D

(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)

Lori h. Why
Director Sign Off

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

510(k) Number

510(k) Number:
	System: HD7 Diagnostic Ultrasound System
Transducer:	989605352341 (C8-5) Curved Linear Transducer
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application				Mode of Operation
General	Specific	B	M	PWD	CWD	Color Doppler	Combined (Specify)	Other* (Specify)
(Track I
Only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative
(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P
	Small Organ (thyroid, scrotum,
prostate, breast)
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)	P	P	P		P	P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Fetal)	P	P	P		P	P	P

Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (Specify)
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	N= new indication; P= previously cleared by FDA; E= added under Appendix E
	*Other modes: Color Power Angio, Harmonics (Tissue), Directional Angio Imaging, Tissue Doppler Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual

Previous Submission: K043535

(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)

Arzuh Wh

(Div/sion Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number_

510(k) Number:
System: HD7 Diagnostic Ultrasound System
Transducer:	989803002683 (C8-4v) Curved Linear Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Specify)	Other* (Specify)
General (Track I Only)
Specific (Tracks I & III)
Ophthalmic
Ophthalmic	P	P	P		P	P	P
Fetal/Obstetric
Abdominal
Intra-operative (vascular/epicardial)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Fetal Imaging & Other
Small Organ (thyroid, scrotum, prostate, breast)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal	P	P	P		P	P	P
Trans-urethral
Trans-esoph. (non-Card.)
Intra-luminal
Other (Gynecological)	P	P	P		P	P	P
Cardiac Adult
Cardiac
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Fetal)
Peripheral
Peripheral vessel
Vessel
Other (Specify)
Musculo-skel (conventional)
Musculo-skel (superficial)

N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: SonoCT, X-Res, Color Power Angio, Panoramic, 3-D Imaging, Directional Angio Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: K043535 for Fetal, Trans-vaginal. K961459 for Fetal, Trans-vaginal, Gynecological.

(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)

Arra In. 22

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

510(k) Number

510(k) Number:
	System: HD7 Diagnostic Ultrasound System
Transducer:	21336A (E6509) Endocavity transducer
	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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P
	Abdominal
	Intra-operative
(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	Small Organ (thyroid, scrotum,
prostate, breast)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Fetal)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	N= new indication; P= previously cleared by FDA; E= added under Appendix E

*Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Tissue doppler Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color

Previous submission: K014191

(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)

Arzu h Zh

(Dision Sign-Off) Division of Reproductive, Abdominal and Radiological Devic

510(k) Number.

Clinical Application		Mode of Operation
General	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
(Track I
Only)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative
(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P
	Small Organ (thyroid, scrotum,
prostate, breast)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)	P	P	P		P	P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Fetal)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (Specify)
	Musculo-skel (conventional)
	Musculo-skel (superficial)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Exaluation

Prescription Use (Per 21 CFR 801.109)

Tony H. Wils

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices

510(k) Number

| | General
(Track I Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(Specify) |
|-----------------------------|-----------------------------------------------------|------------------------------|---|---|-----|-----|------------------|-----------------------|---------------------|
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal
Imaging
& Other | Fetal/Obstetric | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative
(vascular/epicardial) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (thyroid, scrotum,
prostate, breast) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Gynecological) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Fetal) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | P | P | | | | |
| | Other (Specify) | | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | | |

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

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

*Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, iSCAN, Doppler/2D

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evice Evice Evice Evice Evice

Prescription Use (Per 21 CFR 801.109)

logh h Wh

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

510(k) Number A,800548

510(k) Number:	System: HD7 Diagnostic Ultrasound System
Transducer:	21378A (T6H) Omni III Transesophageal Transducer
	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	Color Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal/Obstetric
	Abdominal
	Intra-operative
(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (thyroid, scrotum,
prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Gynecological)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P
	Other (Fetal)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
	Musculo-skel (conventional)
	Musculo-skel (superficial)

	N= new indication; P= previously cleared by FDA; E= added under Appendix E
	*Other modes: Color Power Angio, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging,
Tissue Doppler Imaging

Tissue Doppler Imaging

Combined modes: 2D + Doppler; Triplex = 2D + Doppler + Color,

Previous submission: K043535 for adult, pediatric and transesophageal cardiac

(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)

Arron Z. Zitz

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

510(k) Number K02