ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
Device Facts
| Record ID | K032875 |
|---|---|
| Device Name | ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM |
| Applicant | Aloka Co. Ltd USA |
| Product Code | IYO · Radiology |
| Decision Date | Sep 30, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (See individual transducer indications for specific clinical applications and modes of operation).
Device Story
The Aloka SSD-5500 V6.0 is a diagnostic ultrasound system that uses piezo-electric transducers to transmit high-frequency sound waves into the body. Differences in acoustic impedance of tissues reflect ultrasound energy back to the transducer, which is then processed by the system console into an image. The device also utilizes the Doppler shift of reflected sound from moving tissues (blood) to detect and display flow. It is operated by clinicians in a clinical setting to aid in the diagnosis of disease or abnormality. The system supports various modes including B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Color Doppler, Amplitude Doppler, and mixed modes (e.g., B/M, B/PWD, B/Bflow/PWD). Output is displayed for the clinician to interpret, facilitating clinical decision-making and patient diagnosis.
Clinical Evidence
Bench testing only. The device underwent electrical and physical safety testing, including compliance with IEC-60601-1 (2001-09), UL 2601-1 (1997), and ISO 10993-1:1997 for patient contact materials. Acoustic output levels were verified to be below FDA maximum limits per NEMA-UD2: 1992 and AIUM 1994 standards.
Technological Characteristics
Diagnostic ultrasound system using piezo-electric transducers. Complies with NEMA-UD2: 1992, AIUM 1994, IEC-60601-1 (2001-09 Class A), UL 2601-1 (1997), and ISO 10993-1:1997. Supports B, M, PWD, CWD, Color Doppler, and Amplitude Doppler modes. Connectivity includes probe cable interface to system console.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, intraoperative (liver, pancreas, gall bladder), intraoperative neurological, pediatric, small organ (breast, testes, thyroid), neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vascular, laparoscopic, and musculoskeletal (conventional and superficial) applications. Prescription use only.
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
- Aloka SSD-1700 (K963616)
- Aloka SSD-5500 Ver. 3.1 (K992663)
- Aloka SSD-5500 Ver. 4.2 (K002784)
- Aloka SSD-5500 Ver. 4.2 (K011457)
- Aloka SSD-5500 Ver. 4.2.2 (K011315)
Related Devices
- K041916 — ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM · Aloka Co. Ltd USA · Jul 30, 2004
- K060059 — ALOKA SD-3500 ULTRASOUND SYSTEM · Aloka Co., Ltd. · Jan 13, 2006
- K043196 — ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM · Aloka Co., Ltd. · Nov 30, 2004
- K033311 — ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM · Aloka Co., Ltd. · Oct 29, 2003
- K972465 — ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM · Aloka Co., Ltd. · Aug 15, 1997
Submission Summary (Full Text)
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Aloka Co., Ltd.
510(k)
SEP 3 0 2003
K
#### 510(k) Summary: Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System
This summary statement complies with 21 CFR, section 807.92 as amended March 14. 1995.
This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-5500 V6.0 diagnostic ultrasound system and transducers. The address is:
10 Fairfield Boulevard Wallingford. CT 06492 (203) 269-5088
The contact person is: Richard J. Cehovsky, RA/OA Coordinator
The proprietary name is the Aloka SSD-5500 V6.0 diagnostic ultrasound system and transducers. The common name for this type of device is a diagnostic ultrasound system and transducers.
The item in this submission is covered under the following classification:
| 90 IYN | Ultrasonic Pulsed Doppler Imaging System | 21 CFR 892.1550 |
|--------|------------------------------------------|-----------------|
| 90 ITX | Diagnostic Ultrasound Transducer | 21 CFR 892.1570 |
| 90 IYO | Ultrasonic Pulsed Echo Imaging System. | 21 CFR 892.1560 |
The above as stated in 21 CFR, part 892.1570, 1560 and 1550, has been classified as regulatory Class II.
The Aloka SSD-5500 V6.0 and its transducers are substantially equivalent to its predicates; the Aloka SSD-1700 and SSD-5500 Versions 3.1, 4.2 and 4.2.2 and its transducers.
The Aloka SSD-5500 V6.0 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-5500 V6.0 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The Aloka SSD-5500 V6.0, like other Aloka marketed diagnostic ultrasound systems and transducers are indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
The Aloka SSD-5500 V6.0 diagnostic ultrasound system and transducers are similar in technological characteristics to Aloka's initial predicate ultrasound system: SSD-1700 (K963616) as well as Aloka's SSD-5500 Ver.3.1 (K992663), SSD-5500 Ver.4.2 (K002784/ K011457) and SSD-5500 Ver. 4.2.2 (K011315).
- The SSD-5500 V6.0 is indicated for the same diagnostic ultrasound applications to Aloka's . ultrasound systems: SSD-1700 (K963616), SSD-5500- V3.1, V4.2 , V4.2.2.
- The SSD-5500 V6.0 has the same gray-scale and Doppler abilities to Aloka's ultrasound systems . as mentioned above.
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#### 510(k) Summary: Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System
- . The SSD-5500 V6.0 uses essentially the same technologies for imaging, Doppler functions and signal processing as the following products currently marketed by Aloka : SSD-1700 - (K963616) and SSD-5500- V3.1, V4.2 and V4.2.2 .
- . The SSD-5500 V6.0 has the same method of use as the following products currently marketed by Aloka: SSD-1700 - (K963616) and SSD-5500-V3.1, V4.2 . & V4.2.2.
- . The SSD-5500 V6.0 acoustic power output levels are below the maximum levels allowed by the FDA.
- . The SSD-5500 V6.0 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka such as the: SSD-1700 -{K963616} and SSD-5500- V3.1,V4.2, & V4.2.2.
- . The patient contact materials used in the SSD-5500 V6.0 have been evaluated for safety via the same standards and methods as the above mentioned products marketed by Aloka. These materials have been found to be safe for the intended uses.
- The SSD-5500 V6.0 complies with electrical and physical safety standards as other products . currently marketed by Aloka such as the: SSD-1700 - (K963616) and SSD-5500- V3.1, & V4.2. V4.2.2.
- Aloka Co., Ltd. Certifies that the SSD-5500 V6.0 complies with NEMA-UD2: 1992, AIUM 1994 . "Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment", IEC-60601-1 (2001-09 Class A), UL 2601-1, 2th edition (1997), Part 1, 2th edition including Amendments 1&2 and ISO10993-1:1997. All testing has been completed and the results meet the requirements of the standards above.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread.
Public Health Service
SEP 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K032875
Trade/Device Name: Aloka SSD-5500 V6.0 Diagnostic Ultrasound System 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 Regulatory Class: II Dated: September 11, 2003 Received: September 15, 2003
Dear Mr. Sherratt:
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 Diagnostic Ultrasound System, Model SSD-5500 V 6.0, as described in your premarket notification:
#### Transducer Model Number
| ASU-67-10/7.5 | UC140P-AL5 | UCT140-AL-5 | UST-533 |
|---------------|---------------|-------------|-------------|
| UST-547 | UST-672-5/7.5 | UST-675P | UST-995-7.5 |
| UST-987-7.5 | ASU-1000C-3.5 | ASU-1001 | ASU-1002 |
| ASU-1005 | UST-2265-2 | UST-5268P-5 | UST-5271S-5 |
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Page 2 - Mr. Donald Sherratt
| UST-5276-5 | UST-5280-5 | UST-5281-5 | UST-5286-2.5 |
|---------------|--------------|---------------|---------------|
| UST-5287-3.5 | UST-5293-5 | UST-5294-5 | UST-5296 |
| UST-5524-5 | UST-5524-7.5 | UST-5526L-7.5 | UST-5531 |
| UST-5534T-7.5 | UST-5536-7.5 | UST-5539-7.5 | UST-5543 |
| UST-5545 | UST-5548 | UST-5712 | UST-5713T |
| UST-9101-7.5 | UST-9102-3.5 | UST-9104-5 | UST-9114-3.5 |
| UST-9115-5 | UST-9118 | UST-9119 | UST-9120 |
| UST-9121 | UST-9126 | UST-9128 | UST-52101 |
| UST-52104 | UST-52108 | UST-52109 | UST-MC11-8731 |
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 (OS) 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".
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Page 3 – Mr. Donald Sherratt
If you have any questions regarding the content of this letter, please contact Mr. Rodrigo Perez (301) 594-1212.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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4.3.1
### Diagnostic Ultrasound Indications for Use Form
#### SSD-5500 V6.0
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 | 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 | 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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
FR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032875
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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)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. brogdon
(Division Sign-Off) Division of Reproduc and Radiological Devic 510(k) Number
{7}------------------------------------------------
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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 109
Nancy C. brogdon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
{8}------------------------------------------------
UCT140-AL-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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. brogdon
(Division Sign-Off)
Division of Reprodu ctive. Andal and Radiological Device 510(k) Number
23
{9}------------------------------------------------
UST-533
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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. brogdon
(Division Sign-Off) Division of Reproductive, and Radiological Device 510(k) Number
{10}------------------------------------------------
UST-547
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) | | 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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Device Evaluation (ODE)
CFR 801.109 Nancy C. Brogdon
(Division Sign-Offl
Division of Reproductiv and Radiological Devi 510(k) Number
{11}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form UST-672-517.5
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) | | 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109
FR 801.109ancy C. hogdon
(Division Sign-Off)
Division of Reproductive. A and Radiological Device 510(k) Number .
{12}------------------------------------------------
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) |
| Ophthalmic | | | | | | | | | | |
| 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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sian-Off Division of Reproductive, Abdomin and Radiological Device 510(k) Number
{13}------------------------------------------------
UST-995-7.5
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) | | 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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801
01/09)
Nancy C. brogdon
(Division Sign-Off Division of Reproductive, Abdomin and Radiological Devices - 10(k) Number _______________________________________________________________________________________________________________________________________________________________
{14}------------------------------------------------
UST-987-7.5
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) |
| Ophthalmic | | | | | | | | | | |
| 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 | | | | | | | | | | |
| 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) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.10) Jan C
CFR 801.10 Jancy C. Brogdom
(Division Sign-Off)
Division of Reproductive Abdominal
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{15}------------------------------------------------
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) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy Chroydon
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{16}------------------------------------------------
ASU-1001
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.1
801.109)
Nancy C. hogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
{17}------------------------------------------------
ASU-1002
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) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. Hogdon
(Division Sign-Off) Division of Reproductive, A and Radiological Device 510(k) Number _
{18}------------------------------------------------
ASU-1005
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) | | | | | | | |…
