ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
Device Facts
| Record ID | K033311 |
|---|---|
| Device Name | ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM |
| Applicant | Aloka Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 29, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Device Story
The Aloka SSD-5000 V5.0 is a diagnostic ultrasound system designed for imaging and fluid flow analysis. It processes ultrasonic signals received via various transducers to produce real-time images and Doppler measurements. The system supports multiple modes, including B-mode, M-mode, Pulsed Wave Doppler (PWD), Color Doppler, and Amplitude Doppler. It is intended for use in clinical settings by trained healthcare professionals, such as physicians and sonographers, to assist in diagnostic decision-making across a wide range of anatomical applications. The device provides visual and quantitative data that clinicians use to evaluate patient anatomy and hemodynamics, aiding in the diagnosis and management of various medical conditions.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
The system utilizes ultrasonic pulsed echo and pulsed Doppler imaging principles. It supports a wide array of transducers (e.g., convex, linear, phased array) for various clinical applications. Connectivity includes standard ultrasound system interfaces. The device operates under 21 CFR 892.1550, 892.1560, and 892.1570. Software is embedded firmware for image processing and system control.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal, abdominal, intraoperative (liver, pancreas, gall bladder), intraoperative neurological, pediatric, small organ (breast, testes, thyroid), neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, transurethral, intravascular, peripheral vascular, laparoscopic, and musculoskeletal (conventional and superficial) applications. Prescription use only.
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.
Related Devices
- K111227 — ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM · Aloka Co., Ltd. · May 13, 2011
- K032875 — ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM · Aloka Co. Ltd USA · Sep 30, 2003
- K043196 — ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM · Aloka Co., Ltd. · Nov 30, 2004
- K060059 — ALOKA SD-3500 ULTRASOUND SYSTEM · Aloka Co., Ltd. · Jan 13, 2006
- K041916 — ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM · Aloka Co. Ltd USA · Jul 30, 2004
Submission Summary (Full Text)
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 8 - 2003
Mr. Richard J. Cehovsky RA/QA Coordinator Aloka Co., Ltd. 10 Fairfield Boulevard WALLINGFORD CT 06492-7502
Re: K033311
Trade/Device Name: Aloka SSD-5000 V5.0 Ultrasound System 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: November 11, 2003 Received: November 17, 2003
Dear Mr. Cehovsky:
This letter corrects our substantially equivalent letter of October 29, 2003 regarding the Aloka SSD-5000 V5.0 Ultrasound System. Transducer Model Number: UST-52109 located on page 69 of the original 510(k) was inadvertently omitted from the list below and is now being added.
#### Transducer Model Numbers
| ASU-67-10/7.5 | UST-5281-5 | UST-5712 |
|---------------|---------------|--------------|
| UC140P-AL5 | UST-5284-2.5 | UST-5713T |
| UCT140-AL-5 | UST-5285-3.5 | UST-9101-7.5 |
| UST-533 | UST-5293-5 | UST-9102-3.5 |
| UST-547 | UST-5294-5 | UST-9104-5 |
| UST-672-5/7.5 | UST-5296 | UST-9114-3.5 |
| UST-675P | UST-5297 | UST-9115-5 |
| UST-995-7.5 | UST-5524-5 | UST-9118 |
| UST-987-7.5 | UST-5524-7.5 | UST-9119 |
| ASU-1000C-3.5 | UST-5526L-7.5 | UST-9120 |
| ASU-1001 | UST-5531 | UST-9121 |
| ASU-1002 | UST-5534T-7.5 | UST-9126 |
| ASU-1005 | UST-5536-7.5 | UST-9128 |
| UST-2265-2 | UST-5539-7.5 | UST-52104 |
| UST-5268P-5 | UST-5543 | UST-52108 |
| UST-5271S-5 | UST-5545 | UST-52109 |
| UST-5280-5 | UST-5548 | UST-MC11-873 |
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We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (ffor the indice 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 Press natio Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general contrals provisions of the Act include requirements for annual registration, listing of devices, good manufacturing protise, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 fortuner 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 (2) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set for cract only, 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 continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Complance at (301) 594-4654. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufactures, International and Consumer Assistance at their toll free number (800) 638-2041 or at (31) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
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
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4.3.1
#### Diagnostic Ultrasound Indications for Use Form SSD-5000 V5.0
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) |
| Opthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | See Below | |
| Abdominal | | P | P | P | | P | P | | See Below | |
| Intraoperative (specify) | | P | P | P | | P | P | | See Below | |
| Intraoperative Neurological | | P | P | P | | | P | | See Below | |
| Pediatric | | P | P | P | | P | P | | See Below | |
| Small Organ (specify) | | P | P | P | | P | P | | See Below | |
| Neonatal Cephalic | | P | P | P | | P | P | | See Below | |
| Adult Cephalic | | P | P | P | | P | P | | See Below | |
| Cardiac | | P | P | P | | P | P | | See Below | |
| Transesophageal | | P | P | P | | P | P | | See Below | |
| Transrectal | | P | P | P | | P | P | | See Below | |
| Transvaginal | | P | P | P | | P | P | | See Below | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | | See Below | |
| Laparoscopic | | P | P | P | | P | P | | See Below | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | See Below | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | See Below | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWDIntraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast. testes and thyroid.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Legum
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number .
{3}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form ASU-67-10/7.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | See Below | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
zicion Sign Off
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
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Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | See Below | |
| Intraoperative (specify) | | P | P | P | | P | P | | See Below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | P | P | P | | P | P | | See Below | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.
Intraoperative applications: liver, pancreas and gall bladder
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Seymann
Concurre
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{5}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | | | | | Modes 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) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | See Below | |
| Intraoperative (specify) | | P | P | P | | P | P | | See Below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | P | P | P | | P | P | | See Below | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD
Intraoperative applications: include liver, pancreas and gall bladder.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Symm
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) ( Division of Reproductive, Abdominal and Radiological Devices, 510(k) Number_
{6}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | E | E | E | | E | E | | See Below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD,B/Bflow?PWD
Intraoperative applications: liver, pancreas and gall bladder.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Glynn
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
{7}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | E | E | E | | E | E | | See Below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | E | E | E | | E | E | | See Below | |
| Neonatal Cephalic | | E | E | E | | E | E | | See Below | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small Organ applications: breast, testes, thyroid
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Senger
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
{8}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | P | P | P | | P | P | | See Below | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | See Below | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.
Intraoperative applications: abdominal, bladder, pancreas and gall bladder.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Lehman
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) /
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033311
{9}------------------------------------------------
#### 510(k)
#### Diagnostic Ultrasound Indications for Use Form UST-675P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | See Below | | |
| Transvaginal | | P | P | P | | P | P | | See Below | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | , | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Hygum
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number_
{10}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | P | P | P | | P | P | | See Below | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | P | P | P | | P | P | | See Below | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | | See Below | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.
Applications: Intraoperative: liver, pancreas and gall bladder. Small Organ: breast, testes, thyroid. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Daniel A. Serum
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_
{11}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | P | P | P | | P | P | | See Below | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | | P | P | | See Below | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Lapa:oscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD
Intraoperative applications: include liver, pancreas and gall bladder.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Lynn
(Division Sign-Off) Concurrence
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
{12}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form ASU-1000C-3.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) |
| Opthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | See Below | |
| Abdominal | | P | P | P | | P | P | | See Below | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Legum
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 29 510(k) Number _
{13}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | See Below | | |
| Abdominal | | P | P | P | | P | P | | See Below | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Legan
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _ 30
{14}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) |
| Opthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | See Below | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | P | P | P | | P | P | | See Below | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Daniel A. Seymore
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
{15}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) |
| Opthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | See Below | |
| Abdominal | | E | E | E | | E | E | | See Below | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Degnan
Division Sign Off
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K03331
{16}------------------------------------------------
OS1-220J-2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Modes 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) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Car…
