The Hudson 8000 & 9000 Imaging Systems are diagnostic ultrasound scanners which incorporates a proprietary method of imaging wounds both cavernous and non-cavernous types. The ultrasound scanners use linear array transducers (5-10 Mhz). The scanners are capable of imaging wounds including pressure ulcers which may invade and penetrate tissues as much as 6 cm in some areas of the body.

AI/ML Overview

The provided text describes premarket notifications for the Hudson 8000 and 9000 Ultrasound Systems and their associated transducers. The submission claims substantial equivalence to legally marketed predicate devices, not improvement studies or detailed performance data. Therefore, the information needed to fully answer the request regarding acceptance criteria, study details, and performance metrics is largely unavailable in the provided document.

However, I can extract the explicitly stated intended use for "Wounds" for both systems and relevant transducers, which serves as a form of acceptance criteria for clearance as a new indication.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed reported device performance in the manner of a clinical study demonstrating metrics like sensitivity, specificity, accuracy, etc. The clearance is based on substantial equivalence to predicate devices and the incorporation of a "proprietary method of imaging wounds."

For the new indication for wounds, the "acceptance criteria" is essentially the FDA's determination of substantial equivalence for this specific clinical application, supported by the "Wendelken / Pope method of imaging wounds using diagnostic ultrasound along with predicate and equivalent ultrasound contact media."

Acceptance Criteria (Stated Intended Use for Wounds)	Reported Device Performance
High resolution ultrasound imaging of wounds (Hudson 8000 & 9000 Ultrasound Systems)	Not explicitly detailed as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy). The clearance implies it effectively images wounds, including pressure ulcers which may invade and penetrate tissues as much as 6 cm, when used with the specified method and media.
Wounds imaging (Hudson HL 5-9ED, C2-4ES, C3-7ED, HC2-5ED, EC4-9/10ED, EC4-9ES, UST-5524-7.5)	Not explicitly detailed as quantifiable performance metrics. Clearance implies suitability for this intended use when used with the specified method and media.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on substantial equivalence based on technological characteristics and intended use, not on specific performance data from a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. No specific test set, ground truth establishment, or expert involvement is described in the context of performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in the provided text. The device is an ultrasound scanner, and the "proprietary method" is described as a scanning technique, not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is an ultrasound scanner and the "new indication" for wounds is tied to a specific scanning method, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. Since no specific performance study is detailed, the type of ground truth used for such a study is unknown.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" as this is not an AI/machine learning device submission focused on algorithm training.

9. How the ground truth for the training set was established

This information is not provided in the document and is not applicable as it's not an AI/machine learning device submission.

Summary

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JUN 1 0 2004

PREMARKET NOTIFICATION 510(K) SUMMARY Page 1 of 2

1.	Submitted By:	Hudson Diagnostic Imaging LLC
		610 Boulevard
		Elmwood Park, NJ 07407

Dr. Martin E. Wendelken Contact Person: 2.

3. Name Of Device/s:

a. Trade Names:	Hudson 8000 Ultrasound ScannerHudson 9000 Ultrasound Scanner*
b. Common Name:	Ultrasound Scanner
c. Classification Name:	Ultrasonic pulsed echo imaging systemFR No. 892.1560Product Code: 90-IYN

4. Legally Marketed Device for which we are claiming substantial equivalence:

Scanner Trade Names: Mycolor 202 (Pico) Ultrasound Imaging System* Manufactured and Distributed by:

Medison America Inc. 11075 Knott Avenue Cypress, CA 90630 K031552 Scanner 510(k) Number:

Scanner Trade Names: Aloka SSD-900 Ultrasound Imaging System ** Manufactured and Distributed By:: Aloka Co. Ltd. 10 Fairfield Boulevard

Wallingford, CT 06492

Scanner 510(k) Numbers: K983879

Scanner Trade Names:Hudson 2020, 2040, and 2060 Ultrasound Imaging Systems Distributed by :

Hudson Diagnostic Imaging LLC 610 Boulevard Elmwood Park, NJ 07407 Scanner 510(k) Number: K011284

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PREMARKET NOTIFICATION 510(K) SUMMARY Page 2 of 2

5. Description of the Device:

The Hudson 8000 & 9000 Imaging Systems are diagnostic ultrasound scanners which incorporates a proprietary method of imaging wounds both cavernous and non-cavernous types. The ultrasound scanners use linear array transducers (5-10 Mhz) . The scanners are capable of imaging wounds including pressure ulcers which may invade and penetrate tissues as much as 6 cm in some areas of the body.

6. Intended Use of the Device:

High resolution ultrasound imaging of wounds

7. Summary of Technological Characteristics compared to Predicate Device:

The technological characteristic the predicate devices are equivalent. The incorporation of the Wendelken / Pope method of imaging wounds using diagnostic ultrasound along with predicate and equivalent ultrasound contact media provides for the imaging of wounds.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three stripes on its wing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2004

Dr. Martin E. Wendelken Official Correspondent Hudson Diagnostic Imaging L.L.C. 610 Boulevard ELMWOOD PARK NJ 07407

Re: K040926

Trade Name: Hudson 8000 and 9000 Ultrasound Systems 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: April 7, 2004 Received: April 26, 2004

Dear Dr. Wendelken:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave 1eviewed your bection of society for 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 interstate commerce prov to may 20, 1990, 1990, 1990, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, Allendinents, or to devices market Act (Act). You may, therefore, market the device, subject to I cueral Food, Drug, and Oosmedia Fre Act. The general controls provisions of the Act include the general connents pro risting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the Hudson 9000 Ultrasound System I ins uccemination of Sucstantial equivals and the following transducers intended for with UST-5321 - 715 Tomar System as described in your premarket notification:

HL 5-9ED 5-9 MHz Linear Array C2-4ES Curved Linear Array C3-7ED Curved Linear Array HC2-5ED Curved Linear Array EC4-9/10ED Endocavity Curved Linear Array EC4-9ES Endocavity Curved Linear Array

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), , If your device is classified (sec above) into 5. Existing major regulations affecting your device . EDA It may be subject to such additional connections, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of I each. Fegulations of the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination and mean Please oe advised that FDA s issuation of a budevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other requir that FDA has made a decertimation that your correst by other Federal agencies. You must of any Federal Statutes and regulations administer on thot limited to: registration and listing (21 comply with an the Act 3 requirements, me, good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 807), good in art 820); and if applicable, the electronic form in the quality systems (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 nothication. The IDA inding of succiantial vice 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 If you desire specific advice for your 2011) 594-4591. Additionally, for questions on the comact the Office of Compliance at (301) 594-12 10 Compliance at (30 1) 594promotion and advertising or your as not the drived, "Misbranding by reference to premarket 46.99. Also, please note the regulation entried, "First mission on your responsibilities under the nonification (21 CFR Far 807.77). Sant Schlass (1).
Act may be obtained from the Division of Small Manufacturers, International and Consumer Act may or obtained from the Driller 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,

David br. Ingram

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

Enclosure(s)

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Hudson 8000 Ultrasound System

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. . .

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Diagnositic Unrasound Indications for Use Form

Fili out one form for each ultrasound system and sach transducer.

Intended Use: Diagnostic ultrascund Imaging or fiuld flow analysis of the human body as follows:

Clinical Application		Mode of Operation							Other(specify)
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic									Note 2	Note:3,4,6
Fetal			P	P	P	P			Note 2	Note:3,4,6
Abdominal			P	P	P	P
Intraoperative (specify)
Intraoperative Neurological			P	P	P	P			Note 2	Note:3,4,5
Pediatric			P	P	P	P			Note 2	Note: 3,4,5,6
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic			P	P	P	P			Note 2	Note 7
Cardiac
Transesophageal			P	P	P	P			Note 2	Note 3,6
Transrectal			P	P	P	P			Note 2	Note 3,6
Transurethral
Intravascular
Peripheral Vascular			P	P	P	P			Note 2	Note 3,5,6
Laparoscopic									Note 2	Note3,5,6
Musculo-skeletalConventional			P	P	P	P			Note 2	Note 3,5,6
Musculoskeletal Superficial			P	P	P	P			Note 2
Other (specify)Wounds			N	N	N	N			N-Note 1	Note2,3,6
N= new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Note 1: In conjunction with Wendelken / Pope scanning method and contact media.
Note 2: PWD/Color Doppler, PWD/Power Doppler; CWD/Color Doppler; CWD/ Power Doppler
Note 3: Includes Imaging for guidance of Biospy- Note 4: Tissue Harmonic Imaging
Note 5: Example: Thyroid, ParaThyroid, Breast, Scrotum, & Penis in adult, pediatric and neonatal patients
Note 6: 3D Imaging Note 7: Color M mode NoteHudson 8000 Scanner is a relabeled Medison Pico Scanner
See K031552
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)

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Hudson HL 5-9ED-5-9 Mhz Lincar Array Ultrasound Transducer

. . . .

・・・・・

: :

... :

. . ...

서울 서울 대통령 전문 대통령 대통령 대통령

. .

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

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

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P			P- Notes: 1,2,3,4
Small Organ (specify)		P	P	P		P			P- Notes: A,1,2,3
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P			P- Notes: 1,2,3
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P			P- Notes: 1,2,3
Musculo-skeletal Superficial		P	P	P		P			P- Notes: 1,2,3
Other (specify) Wounds		N		N		N			N-Note 1	Note:2,3
N= new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: In conjunction with Wendelken / Pope scanning method and contact media,
Note A: Thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 1: PWD/Color Doppler, PWD/Power Doppler Note 2: 3D imaging
Note 3: CWD/ Color Doppler, CWD/Power Doppler Note 4: Tissue Harmonic imaging
Note 5: The Hudson HL 5-9ED probe is a relabeled Medison III, 5-9 ED probe--See K031552
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac Adult		P	P	P		P			Note: 1	Note: 2
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial

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

Hudson C2-4ES- Curved Linear Array Transducer

ಿಗೆ ಅತ್ಯೆ ಅತ್ಯ ಅವರ ಬೆಳೆದು ಪ್ರಮುಖ ಪ್ರಮ
ವಿದ್ಯಾಂಕ ಸಾಮಾನ್ಯವಾಗಿ ಮತ್ತು ಪ್ರದೇಶದಿಂದ ಪ್ರದೇಶದಿಂದ ಪ್ರದೇಶದಿಂದ ಪ್ರಮುಖ
ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮು

.. , . . . .

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. . . .

. . .

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ﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ・

Diagnostic Ultrasound Indications for Use Form

Fill out one form for asch ultrasound system and sach transducar.

Intended User. Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:

N= new Indication; P= previously deared by FDA; E= added under Appendix E

Additional Comments;

Note I: PWIX/Color Doppier, I'WD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler Note 2: Color M Mode

Note 3: The Hudson C2-4 1:S probe is a relabeled Medison C2-4 F.S probe See K031552

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)	Division of Reproductive, Abdominal, and Radiological Devices
	K Number: K040926

46-13

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Hudson C3-7ED- Curved Linear Array Transduccr

Diagnostic Uttrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer,

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal		P	P	P		P			Note: 1	Note: 2,3,4
Abdominal		P	P	P		P			Note: 1	Note: 2,3,4
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P			Note: 1	Note: 2,3,4
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial

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

Additional Comments:

Note J PWD/Color Doppler, PWD/Power Doonler, CWD/Color Doppler, CWD/Power Doppler,

Note 2: Includes imaging for guidance of biospy Note 3: Tissue Harmonic Imaging Note 4: 3D Imaging Note 4: The Hudson C3-7 F.D probe is a relabeled Medison C3-7 LLD probe-See K031552

(PLEASE OO MOT WARTE BOLOW THIS LINE - CONTI of the of CORPL OF

Prescription Use (Per 21 CFR 801.109)

Division: Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K040926

46-C

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

Hudson C3-7ED- Curved Linear Array Transduccr

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and sach transducer.

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic									Note: 1	Note: 2,3,4
Fetal		P	P	P		P			Note: 1	Note: 2,3,4
Abdominal		P	P	P		P			Note: 1	Note: 2,3,4
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P			Note: 1	Note: 2,3,4
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:

Note 1: PWD/Color Doppler, PWD/Pqwer Doopler, CWD/Color Doppler, C.WD/Power Doppler,

Note 2: Includes imaging for guidance of biospy Note 3: Tissue Harmonic Imaging Note 4: 3D Imaging Note 4: The Hudson C3-7 FD probe is a relabeled Medison C3-7 LD probe-See K031552

(PLEADE OID MOT WRITT BICLOW THIS LINE - CONTINUE ON ANOTH currence of CORPL Of

Prescription Use (Per 21 CFR 801.109)

Division Sign-Off) 1
Division of Reproductive, Abdominal,
ano Radiological Devices
510(k) Number K040926

46-C

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

Hudson HC2-5ED - Curved Linear Array Transducer

... :"

: .

. . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. .

、

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the humen body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Color VelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal	P	P	P	P		P			Note: 1	Note: 2,3,4
Abdominal	P	P	P	P		P			Note: 1	Note: 2,3,4
Intraoperative (specify)
Interoperative Neurological
Pediatric	P	P	P	P		P			Note: 1	Note: 2,3,4
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new Indication; P= praviously deared by FDA; E= added under Appendox E

Additional Comments:

Note 1:19W1)/Color Doppler, PWD/Pawer Doppler, CWD/Color Dappler, CWD/Power Doppler, Note 2: Includes imaging for guidance of biospy Note 3: Tissue Harmonic Imaging Note 4: 3D Imaging

Note S: The Hudson HC2-5 ED probe is a relabeled Medison HC2 2-5 F.D probe Sec K031552

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	Division Sign-Off)
	Division of Reproductive, Abdominal, and Radiological Devices
Prescription Use (Per 21 CFR 801.109)
	K Number: K040926

{10}------------------------------------------------

Hudson EC4-9/10ED- Endocavity Curved Lincar Array

Diagnostic Ultrasound Indications for Use Form

Fili out one form for each ultrasound system and each transducer.

: . .

: : : . . :

. . . .

: :

: : . .

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

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P			Note: 1	Note:2,4
Transvaginal		P	P	P		P			Note: 1	Note:2,3,4
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development Note 4: 3D Imaging

Note 5: The Hudson EC 4-9/10ED probe is a relabeled Medison EC 4-9/10 ED probe. See K031552

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)

Prescription Use (Par 21 CFR 801.109) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K040926

{11}------------------------------------------------

Hudson EC4-9ES- Endocavity Curved Linear Array

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrascund Imaging or flutó flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P			Note: 1	Note: 2, 4
Transvaginal		P	P	P		P			Note: I	Note:2,3,4
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Another Lanardal

v indication; P= pravlously deared by FDA; E= added under Appendix E

Additional Comments:

Note LPWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler

Note 2: Includes imaging for guidance of hiospy

Note 3: Includes infertility monitoring of folliele development

Note 4: 3D Imaging

Note 5: The Hudson EC4-9ES probe is a relabeled Medison EC4-9 US probe-See K031552

of COREA, Only

(PLEASE OO MOT WRITE BELOW THIS UNE - COMMONLE ON

David A. Ingram

Prescription Use (Per 21 CFR 801.109)

Thision of Reproductive, Abdominal, and Padiological D 140%) . umber

46-F

{12}------------------------------------------------

Hudson 9000 Ultrasound System

Diagnountic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic		P	P						B/M
Fetal		P	P						B/M
Abdominal		P	P						B/M
Intraoperative		P	P						B/M
Intraoperative Neurological		P	P						B/M
Pediatric		P	P						B/M
Small Organ (specify)		P	P						B/M	Note 2
Neonatal Cephalic		P	P						B/M
Adult Cephalic		P	P						B/M
Cardiac Pediatric
Transesophageal		P	P						B/M
Transrectal		P	P						B/M
Transvaginal
Transurethral
Intravascular		P	P						B/M
Peripheral Vascular		P	P						B/M
Laparoscopic		P	P						B/M
Musculo-skeletal Conventional
Musculo-skeletal Superficial Wounds										Note 1
Other (specify)		N	N						B/M

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

Additional Comments:

Note I : In conjunction with Wendelken / Pope scanning method and contact media.

Note 2: Thyroid, Parathyroid, Breast, Scrotum, Penis in adult, Pediatric and Neonatal Patents

Scc K983879 Note 3: The Hudson 900 Ultrasound System is a relabeled Aloka 900 Ultrasound System

al CORH Oth

David C. Wegman

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

Prescription Use (Per 21 CFR 801.109)

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Hudson UST-5524-7.5 40mm Lincar Array Ultrasound Transducer

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Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and sach transducer.

Intended Use: Diegnostic ultrasound imaging or fiuld flow ansilysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P						B/M	Note:2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P						B/M
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial		N	N						N-B/M	Note 1

on= (quol) = winnius) = previously cleared by FDA: E= added under Appendix E

Additional Comments:

Donal Comments.

Note 2: Thyroid, Parathyroid, Breast, Scrotum, Penis in adult, Pediatric and Neonatal Patents

Note 3: The Hudson UST-5524 probe is a relabeled Aloka UST-5524 probe -- See K983879

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


	(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)	Division of Reproductive, Abdominal, and Radiological Devices
	510(k) Number K040926

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.