U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
Device Facts
| Record ID | K013848 |
|---|---|
| Device Name | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 |
| Applicant | U-Systems, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 8, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
Indications for Use
The modified U-2000 is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3 dimensional image processing.
Device Story
USI-2000 Diagnostic Ultrasound System; modified software enables acquisition, analysis, storage, and retrieval of digital 3D ultrasound image data sets; provides multiplanar reformatting capabilities; system utilizes 7.5 MHz and 10 MHz transducers; intended for clinical use in abdominal, small organ, peripheral vascular, and musculo-skeletal applications; physician-operated; output consists of 3D reconstructed diagnostic ultrasound images; aids clinical decision-making through computerized 3D image processing.
Clinical Evidence
Bench testing only. Software validated according to company quality assurance procedures.
Technological Characteristics
Diagnostic ultrasound system; 7.5 MHz and 10 MHz transducers; pulsed echo and pulsed Doppler imaging; digital 3D image processing; multiplanar reformatting; software-based analysis.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in abdominal, small organ (breast, thyroid, testes), peripheral vascular, and conventional musculo-skeletal applications. Modes include B, M, PWD, Color Doppler, and Amplitude Doppler.
Regulatory Classification
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.
Predicate Devices
- Echotech 3D Freescan
Submission Summary (Full Text)
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K013848
CONFIDENTIAL U-Systems Inc.510(k) Notification evice Modification
# APR = 8 2002
### 2.4 510(k) Summary
## 510(k) Summary U-Systems Ultrasound System U-Systems INC. Prepared November 15, 2001
| Product Name: | U-2000 Ultrasound System |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | U-Systems Inc. |
| Generic Name | Diagnostic Ultrasound System |
| Classification Name: | Ultrasound Imaging System and Transducers (Class II); Classification<br>codes:<br>IYO 892.1560 System, Imaging Pulsed Echo, Ultrasonic<br>IYN 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic<br>ITX 892.1570 Transducer, Ultrasonic, Diagnostic |
| Contact Person: | Sheila W. Pickering Ph.D.<br>2081 Longden Circle<br>Los Altos, California 94024<br>Telephone/Fax 650 969 6114 |
#### A. Legally Marketed Predicate Device
The modification to the U-2000 software is substantially equivalent to the Echotech 3D Freescan with regard to features, specifications, and intended use.
e-mail: swpraqa@aol.com
#### B. Device Description
The modified U-2000 software provides the capability for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets and multiplaner reformatting capabilities.
### C. Intended Use
The modified U-2000 is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3 dimensional image processing.
### D. Substantial Equivalence
The U-2000 is substantially equivalent to the Echotech 3D Freescan, which is currently in commercial distribution.
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## E. Performance Data
The modified software has been validated according to the company's software quality assurance procedures, as certified in the original 510(k) Notification.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sheila W. Pickering, Ph.D. Regulatory Affairs Consultant U-Systems, Inc. 2081 Longden Circle LOS ALTOS CA 94024
Re: K013848
Trade Name: USI-2000 Diagnostic Ultrasound System, Modified Software Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: 90 ITX Regulatory Class: II Dated: February 27, 2002 Received: March 1, 2002
Dear Dr. Pickering:
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 USI-2000 Diagnostic Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
## 7.5 MHz 10 MHz
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## Page 2 - Dr. Pickering
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 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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 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.
Nancy C. Brogdon
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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CONFIDENTIAL U-Systems Inc.510(k) Notification USI-2000 Diagnostic Ultrasound System
## Diagnostic Ultrasound Indications for Use
510(k) Number(s):
N/A
Device Name:
USI-2000 Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use:
| | Mode of Operation | | | | | | | | | |
|------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify)* | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | Note 1 | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast, thyroid,<br>testes) | | N | N | N | | N | N | | Note 1 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laproscopic | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | Note 1 | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | N | | Note 1 | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Amplitude Doppler; B/Color Doppler/PWD and B/Amplitude Doppler/PWD
N = new indication
P = previously cleared by FDA
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Haneye Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Dai
022
*Prescription Use*
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CONFIDENTIAL U-Systems Inc.510(k) Notification USI-2000 Diagnostic Ultrasound System
## Diagnostic Ultrasound Indications for Use
510(k) Number:
N/A
Device Name:
7.5 MHz Transducer Diagnostic Ultrasound Transducer
Intended 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify)* | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | Note 1 | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast, thyroid,<br>testes) | | N | N | N | | N | N | | Note 1 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laproscopic | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | Note 1 | |
| Musculo-skeletal | | N | N | N | | N | N | | Note 1 | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
Note 1: Combined includes: BBM; B/PWD; B/Color Doppler; B/Amplitude Doppler; B/Color Doppler/PWD and B/Amplitude Doppler/PWD
N = new indication P = previously cleared by FDA
> . (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > ിപ്
*Prescription Use* ✓
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 023
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CONFIDENTIAL U-Systems Inc.510(k) Notification USI-2000 Diagnostic Ultrasound System
## Diagnostic Ultrasound Indications for Use
510(k) Number:
N/A
Device Name:
10 MHz Transducer Diagnostic Ultrasound Transducer
Intended 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify)* | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | Note 1 | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast, thyroid,<br>testes) | | N | N | N | | N | N | | Note 1 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laproscopic | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | Note 1 | |
| Musculo-skeletal | | N | N | N | | N | N | | Note 1 | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Amplitude Doppler; B/Color Doppler/PWD and B/Amplitude Doppler/PWD
N = new indication P = previously cleared by FDA
> (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon 024
of Reproduct ive. Al diological De 15 510(k) Numb
Prescription Use
