(63 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound technology.
No
The device is described as a diagnostic ultrasound scanner for imaging wounds, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also refers to the systems as "diagnostic ultrasound scanners".
No
The device description explicitly states it is a diagnostic ultrasound scanner that incorporates linear array transducers, which are hardware components.
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. They are used outside of the living body.
- Device description: The Hudson 8000 & 9000 Imaging Systems are described as "diagnostic ultrasound scanners." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures within the living body.
- Intended Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This clearly indicates the device is used on the patient, not on a sample taken from the patient.
- Anatomical Site: The listed anatomical sites are all parts of the human body.
Therefore, the Hudson 8000 & 9000 Imaging Systems are in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
- Hudson 8000 & 9000 Ultrasound System: High resolution ultrasound imaging of wounds
- Hudson 8000 Ultrasound System: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative Neurological, Pediatric, Adult Cephalic, Transesophageal, Transrectal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculoskeletal Superficial, Wounds.
- Hudson HL 5-9ED-5-9 Mhz Lincar Array Ultrasound Transducer: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Pediatric, Small Organ, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Wounds, Cardiac Adult.
- Hudson C2-4ES- Curved Linear Array Transducer: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Peripheral Vascular, Laparoscopic, Musculoskeletal Conventional, Musculoskeletal Superficial.
- Hudson C3-7ED- Curved Linear Array Transduccr: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Ophthalmic.
- Hudson HC2-5ED - Curved Linear Array Transducer: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric.
- Hudson EC4-9/10ED- Endocavity Curved Lincar Array: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transrectal, Transvaginal.
- Hudson EC4-9ES- Endocavity Curved Linear Array: Diagnostic ultrascund Imaging or flutó flow analysis of the human body as follows: Transrectal, Transvaginal.
- Hudson 9000 Ultrasound System: Diagnostic ultrasaund imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Transesophageal, Transrectal, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Superficial Wounds.
- Hudson UST-5524-7.5 40mm Lincar Array Ultrasound Transducer: Diegnostic ultrasound imaging or fiuld flow ansilysis of the human body as follows: Small Organ, Peripheral Vascular, Musculo-skeletal Superficial.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, IYO, and ITX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Wounds (cavernous and non-cavernous, including pressure ulcers), Ophthalmic, Fetal, Abdominal, Intraoperative (general, neurological), Pediatric, Small Organ (Thyroid, Parathyroid, Breast, Scrotum, Penis), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal (Conventional, Superficial). Some clinical applications are specified for use in adult, pediatric, and neonatal patients.
Indicated Patient Age Range
Adult, Pediatric, Neonatal (specific to certain applications)
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): 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.
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
§ 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.
0
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 Scanner*
Hudson 9000 Ultrasound Scanner** |
|-------------------------|----------------------------------------------------------------------------------|
| b. Common Name: | Ultrasound Scanner |
| c. Classification Name: | Ultrasonic pulsed echo imaging system
FR No. 892.1560
Product 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
1
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)
4
Hudson 8000 Ultrasound System
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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 | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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-skeletal
Conventional | | | 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) | | | | | | | | | | |
5
Hudson HL 5-9ED-5-9 Mhz Lincar Array Ultrasound Transducer
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・・・・・
: :
... :
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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 | 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 Adult | P | P | P | P | Note: 1 | Note: 2 | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial |
6
Hudson C2-4ES- Curved Linear Array Transducer
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:
ಿ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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. . . .
. . .
.
:
:
. ··
:
:
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
7
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
:
1
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 | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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-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/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
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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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color Velocity | |||||||||
| Imaging | 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-skeletal | ||||||||||
| Conventional | ||||||||||
| 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.
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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 | 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: I | Note:2,3,4 | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| 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)
13
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 |