DIASUS

K013142 · Dynamic Imaging , Ltd. · IYO · Oct 5, 2001 · Radiology

Device Facts

• Record ID: K013142
• Device Name: DIASUS
• Applicant: Dynamic Imaging , Ltd.
• Product Code: IYO · Radiology
• Decision Date: Oct 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for Use

The Diasus Ultrasound Imaging system is intended for performing no-invasive diagnostic general ultrasound studies. Such uses include the following; Abdominal, Cardiac, Paediatric, Small organs including, Thyroid, Parathyroid, Breast and Testes, Neonatal / adult cephalic, Peripheral vascular, and Conventional / Superficial Musculoskeletal.

Device Story

Diasus is a diagnostic ultrasound imaging system; utilizes linear array transducers (5-22 MHz) to acquire B-mode images; used in clinical settings by healthcare professionals for non-invasive visualization of internal structures; supports needle guidance for interventional procedures; features cine loop, measurement tools (distance, area, circumference), and optional DICOM connectivity; output displayed on 15-inch monitor; assists clinicians in diagnostic assessment and procedural guidance; benefits patients through non-invasive imaging and accurate needle placement.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, comparison of technological characteristics, and adherence to recognized safety standards (IEC601-1, IEC601-1-2, EN61157).

Technological Characteristics

Diagnostic ultrasound system; linear array transducers; frequency range 5-22 MHz; B-mode imaging; 15-inch monitor; Centronics and SCSI interfaces; optional DICOM connectivity; compliant with IEC601-1, IEC601-1-2, and EN61157; CE marked.

Indications for Use

Indicated for diagnostic ultrasound imaging in adult, pediatric, and neonatal patients for abdominal, cardiac, small organ (thyroid, parathyroid, breast, testes), neonatal/adult cephalic, peripheral vascular, and musculoskeletal (conventional/superficial) applications. Includes needle guidance.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• AU4 (K944485)
• AU5 (K980468)
• AU6 (K990360)

Submission Summary (Full Text)

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K013142

| Attachment 2 | 510(k) Summary<br>Dynamic Imaging Diasus | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Submitter | Dynamic Imaging Ltd<br>9 Cochrane Square<br>Brucefield Industrial Park<br>Livingston<br>EH54 9DR<br>UK | |
| OCT - 5 2001 | Mr Allan Findlay | |
| Telephone:<br>Fax:<br>Email: | 011 44 (0) 1506 415282<br>011 44 (0) 1506 410603<br>[e-mail] | |
| Date prepared | 7 August 2001 | |
| Propriety Name of Device | Diasus | |
| Common or Usual Name | Diagnostic Ultrasound System with Accessories | |
| Classification Name | Ultrasonic Pulsed Echo Imaging System | FR Number Product Code<br>892.1560 90-IYO |
| Predicate Devices | | |
| Trade name | Manufacturer | 510(k) |
| AU4 | Biosound Asaote Inc | K#944485 |
| AU5 | Biosound Asaote Inc | K#980468 |
| AU6 | Biosound Asaote Inc | K#990360 |
| The Diasus is of comparable type and substantially equivalent to the legally marketed Biosound Asaote Inc<br>AU4, AU5 and AU6. It has the same technology characteristics, is comparable in key safety and effectiveness<br>features, and all its intended uses and operating modes are available in the predicative devices. | | |
| Additional Substantial Equivalence Information is provided in the following Comparison to Predicate Device<br>table. | | |
| Intended Uses | | |

The Diasus Ultrasound Imaging system is intended for performing no-invasive diagnostic general ultrasound studies. Such uses include the following; Abdominal, Cardiac, Paediatric, Small organs including, Thyroid, Parathyroid, Breast and Testes, Neonatal / adult cephalic, Peripheral vascular, and Conventional / Superficial Musculoskeletal.

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Dynamic Imaging Ltd
510(k) - Diasus - Indications for Use

Attachment 2
Page 2 of 2

### Comparison to Predicate Devices

| General | Dynamic | Esaote | Esaote | Esaote |
|---------------------------------------|--------------------------------------|------------------------|------------------------|----------------------|
| Characteristics | Imaging Diasus | AU6 | AU5 | AU4 |
| | | K#990360 | K#980468 | K#944485 |
| Transducer types | | Annular Array | Annular Array | Annular Array |
| | | Mechanical | Mechanical | Mechanical |
| | | Sector | Sector | Sector |
| | Linear | Linear | Linear | Linear |
| | | Convex | Convex | Convex |
| | | Phased Array | Phased Array | Phased Array |
| Frequency | 5 to 22 MHz | 2.5 to 20 MHz | 2.5 to 20 MHz | 2.5 to 20 MHz |
| Imaging Modes | | | | |
| A | | | | |
| B | YES | Yes | Yes | Yes |
| M | | Yes | Yes | Yes |
| PWD | | Yes | Yes | Yes |
| CWD | | Yes | Yes | Yes |
| Colour Doppler CFM | | Yes | Yes | Yes |
| Amplitude Doppler PD | | Yes | Yes | Yes |
| Colour Velocity Imaging | | | | Yes |
| Combined | | Yes | Yes | Yes |
| Cine Loop Facility | Yes | Yes | Yes | Yes |
| Biopsy attachments | Linear Array | Linear Array<br>Convex | Linear Array<br>Convex | Linear Array |
| Measurements | | | | |
| Distance | Yes | Yes | Yes | Yes |
| Area | Yes | Yes | Yes | Yes |
| Circumference | Yes | Yes | Yes | Yes |
| Monitor Size (nominal) | 15 inches | 15 inches | 15 or 14 inches | 14 or 12 inches |
| Programmability | Only limited<br>by<br>hard disk size | 10 presets | 6 presets | |
| Computer interface | Centronics<br>output | Centronics<br>output | Centronics<br>output | Centronics<br>output |
| | SCSI in/out port | | | |
| Printer | Yes | Yes | Yes | Yes |
| DICOM communications | Yes optional | | | |
| External Dimensions | | | | |
| Width | 500mm | 580mm | 540mm | 500mm |
| Height | 1268mm | 11440mm | 11440mm | 1245mm |
| Depth | 804mm | 1100mm | 690mm | 700mm |
| Standards | IEC601-1<br>IEC601-1-2<br>EN61157 | IEC601-1 | IEC601-1 | IEC601-1 |
| Medical Device Directive<br>CE marked | Yes | Yes | Yes | Yes |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus, featuring three curved lines that suggest a bird or a flowing design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 5 2001

Dynamic Imaging % R. Kent Donohue Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 RESEARCH TRIANGLE PARK NC 27709

Re: K013142

Trade Name: Diasus Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: September 17, 2001 Received: September 20, 2001

Dear Mr. Donohue:

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 Diasus, as described in your premarket notification:

#### Transducer Model Number

| P75LHF<br>、 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| P12LHF<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| PIELHE |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy C. Brogdon
Director, Division of Reproductive

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Image /page/5/Picture/0 description: The image shows the logo for Dynamic Imaging Ltd. The logo consists of the company name, "Dynamic Imaging Ltd", and the text "510(k) - Diasus" below it. To the left of the text is a stylized letter D.

## 4.3.1 510(k) Indications for Use Form

510K number (if Known) :

K 013142

Device:

Diasus, Diagnostic Ultrasound System

Diagnostic Ultrasound imaging of the human body as follows Intended Use :

| | Mode of Operations | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|------------------------------|----------|----------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | | | | | | | | Note 2 |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | | | | | | | | Note 2 |
| Small Organ (Specify) | | N | | | | | | | | Note 1,2 |
| Neonatal Cephalic | | N | | | | | | | | |
| Adult Cephalic | | N | | | | | | | | |
| Cardiac | | N | | | | | | | | |
| Transesophagael | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | | Note 2 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | | | | | | | | Note 2 |
| Musculo-skeletal Superficial | | N | | | | | | | | Note 2 |
| Other | | | | | | | | | | |

N = New Indication, P = Previously Cleared by FDA, E = Added under Appendix E Additional Comments :

For Example : Note 1

Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients

Note 2

Includes imaging for needle guidance

Prescription Use (as per 21CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013142

Page । उ

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Image /page/6/Picture/0 description: The image shows a logo for Dynamic Imaging Ltd. The text "Dynamic Imaging Ltd" is written in a clear, bold font. Below the company name, it says "510(k) - Diasus". The logo is simple and professional, suggesting a company that specializes in imaging technology.

Indications for Use Form

510K number (If Known) :

K013142

Device:

P75LHF, 5-12MHz Ultra wideband Linear Array Probe

Intended Use :

Diagnostic Ultrasound imaging of the human body as follows

| Clinical Application | Mode of Operations | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|------------------------------|----------|----------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | | | | | | | | Note 2 |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | | | | | | | | Note 2 |
| Small Organ (Specify) | | N | | | | | | | | Note 1,2 |
| Neonatal Cephalic | | N | | | | | | | | |
| Adult Cephalic | | N | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophagael | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | | Note 2 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | | | | | | | | Note 2 |
| Musculo-skeletal Superficial | | N | | | | | | | | Note 2 |
| Other | | | | | | | | | | |

N = New Indication, P=Previously Cleared by FDA, E = Added under Appendix E Additional Comments : For Example : Note 1

Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients

Note 2

Includes imaging for needle guidance

Prescription Use (as per 21CFR 801.109)

Ad
(DMision Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013142
510(k) Number

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Image /page/7/Picture/0 description: The image shows a close-up of a letter, possibly 'D' or 'C', in a bold, black font. The letter is large and fills most of the frame, with only a small portion of the surrounding background visible. The black ink is solid and creates a strong contrast against the white background.

Dynamic Imaging Ltd 510(k) - Diasus

### Indications for Use Form

510K number (if Known) :

# K 013142

Device:

# P12LHF, 8-16MHz Ultra wideband Linear Array Probe

Intended Use :

Diagnostic Ultrasound imaging of the human body as follows

| Clinical Application | Mode of Operations | | | | | | | | | |
|------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|------------------------------|----------|----------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | | | | | | | | Note 2 |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | | | | | | | | Note 2 |
| Small Organ (Specify) | | N | | | | | | | | Note 1,2 |
| Neonatal Cephalic | | N | | | | | | | | |
| Adult Cephalic | | N | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophagael | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | | Note 2 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | N | | | | | | | | Note 2 |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | N | | | | | | | | Note 2 |
| Other | | | | | | | | | | |

N = New Indication, P=Previously Cleared by FDA, E = Added under Appendix E

Additional Comments :

Note 1

For Example : Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients

Note 2

Includes imaging for needle guidance

Prescription Use (as per 21CFR 801.109)

(Division Sign-Of
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013142

Page

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Image /page/8/Picture/0 description: The image shows the logo and name of a company called Dynamic Imaging Ltd. The text "510(k) - Diasus" is written below the company name. The logo is on the left side of the image and consists of a stylized letter D.

### Indications for Use Form

510K number (if Known) :

K 013142

### Device:

## P16LHF, 10-22MHz Ultra wideband Linear Array Probe

Intended Use :

Diagnostic Ultrasound imaging of the human body as follows

| Clinical Application | Mode of Operations | | | | | | | | | Other |
|------------------------------|--------------------|---|-----|-----|------------------|----------------------|------------------------------|----------|--|----------|
| A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined | | |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | | | | | | | | Note 2 |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | | | | | | | | Note 2 |
| Small Organ (Specify) | | N | | | | | | | | Note 1,2 |
| Neonatal Cephalic | | N | | | | | | | | |
| Adult Cephalic | | N | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophagael | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | | Note 2 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | N | | | | | | | | Note 2 |
| Conventional | | N | | | | | | | | Note 2 |
| Musculo-skeletal Superficial | | N | | | | | | | | Note 2 |
| Other | | | | | | | | | | |

N = New Indication, P=Previously Cleared by FDA, E = Added under Appendix E

Additional Comments :

Note 1

For Example : Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients

Note 2

Includes imaging for needle guidance

Prescription Use (as per 21CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013142
510(k) Number

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