ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K083254 |
|---|---|
| Device Name | ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Aloka Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Dec 19, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intra-operative, Transrectal and Abdominal applications. The device is not indicated for Ophthalmic applications.
Device Story
Aloka Prosound 2 is a portable, full-digital diagnostic ultrasound system. It utilizes ultrasound transducers to acquire images and fluid flow data from the human body. The system features a high-resolution LCD flat panel monitor, a computer-style keyboard, and specialized controls for image processing and analysis. It is intended for use by qualified physicians in clinical settings. The device processes acoustic signals to produce real-time diagnostic images, aiding clinicians in evaluating various anatomical structures and physiological conditions. By providing high-quality imaging and analysis, the system supports clinical decision-making for diagnosis and patient management across multiple medical specialties.
Clinical Evidence
No clinical data was required. Substantial equivalence is supported by non-clinical bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, electromagnetic compatibility, and electrical/mechanical safety testing, all of which confirmed conformance to applicable medical device safety standards.
Technological Characteristics
Portable, full-digital diagnostic ultrasound system. Features high-resolution LCD flat panel monitor and computer-style keyboard. Supports multiple transducer models. Operates using ultrasonic pulsed Doppler and pulsed echo imaging. Conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. Safety verified through independent evaluation of acoustic output, biocompatibility, and electrical/mechanical safety.
Indications for Use
Indicated for ultrasound evaluation of gynecological, fetal, peripheral vascular, cardiac, neonatal cephalic, small parts (breast, testes, thyroid), intra-operative (liver, pancreas, gall bladder), transrectal, and abdominal applications in patients requiring diagnostic ultrasound imaging. Contraindicated for ophthalmic applications.
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
- Aloka SSD-500 (K900805)
Reference Devices
- UST-5561-7.5 (K840540)
- UST-556T-7.5 (K840540)
- UST-556TU-7.5 (K870916)
- UST-586-5 (K861538)
- UST-5871-5 (K840540)
- UST-660-7.5 (K870916)
- UST-934N-3.5 (K900805)
- UST-935N-5 (K900805)
- UST-944B-3.5 (K870916)
- UST-945B-5 (K900805)
- UST-974-5 (K910153)
- UST-981-5 (K900805)
- UST-5512U-7.5 (K861538)
- UST-5551 (K861538)
- UST-5711 (K861538)
- UST-5820-5 (K840540)
- UST-9111-5 (K910153)
- UST-9137 (K900805)
Submission Summary (Full Text)
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510(K)
KCJ3254
# DEC 1 9 2008
# 510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92
Section a): 1. Submitter: Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492 Richard J. Cehovsky, RA/QA Coordinator, Contact Person: Tel: (203)269-5088 Ext. 346, Fax: 203-269-6075 Date Prepared: 9/18/08 2. Device Name: Aloka Prosound 2 Diagnostic Ultrasound System Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 , 90 IYN Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITX Ultrasonic Pulsed Echo Imaging System., 21 CFR 892.1560, 90 IYO Aloka SSD-500 Diagnostic Ultrasound System K900805, (90-IYN, ITX, IYO) 3. Marketed Device: ( A device currently in commercial distribution) 4. Device Description: The Aloka Prosound 2 Diagnostic Ultrasound System is a light weight, full-digital portable imaging and analysis system. It consist of a high resolution LCD flat panel monitor that provides excellent image quality and processing . The user interface includes a computer type keyboard. specialized controls and a display. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of 5. Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intraoperative, Transrectal and Abdominal applications. The device is not indicated for Ophthalmic applications. 6.Comparison w/ Predicate Device: The Aloka Prosound 2 is technically comparable and substantially equivalent to the current Aloka SSD-500-(K900805). It has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate device. Section b): 1. Non-clinical Tests: The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards. 2. Clinical Tests: None Required. 3. Conclusion: Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka Prosound 2 Diagnostic Ultrasound System and its transducers are substantially equivalent with respect
to safety and effectiveness to its predicate and other currently cleared Aloka systems.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
000 2 2 2009
Aloka Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K083254
Trade/Device Name: Aloka Prosound 2 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 2, 2008 Received: December 4, 2008
Dear Mr. Borsai:
J
This letter corrects our substantially equivalent letter of December 19, 2008.
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 Aloka Prosound 2, as described in your premarket notification:
#### Transducer Model Number
| UST-5561-7.5 | UST-660-7.5 |
|---------------|--------------|
| UST-556T-7.5 | UST-934N-3.5 |
| UST-556TU-7.5 | UST-935N-5 |
| UST-586-5 | UST-944B-3.5 |
| UST587I-5 | UST-945B-5 |
{2}------------------------------------------------
| UST-974-5 | UST-5711 |
|---------------|------------|
| UST-981-5 | UST-5820-5 |
| UST-5512U-7.5 | UST-9111-5 |
| UST-5551 | UST-9137 |
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Harald Lemke
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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# Section 1.3 Indications for Use
# Section 1.3.1
# 510(k) Indications for Use Statement/Forms
( Immediately follows this page)
{4}------------------------------------------------
# Indications for Use
#### 510(K) Number (if known):
Device Name:
Aloka Prosound 2
Indications For Use:
The device is intended for use by a qualified physician for ultrasound evaluation of Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intra-operative, Transrectal and Abdominal applications.
The device is not indicated for Ophthalmic applications.
Prescription Use P (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
# IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of Device Evaluation (ODE)
Hertenn
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 8355 510(k) Number
Page 1 of 1
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1.3.1
#### Diagnostic Ultrasound Indications for Use Form Prosound 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 | | N | N | | | | | | See Below | |
| Abdominal | | N | N | | | | | | See Below | |
| Intraoperative (specify) | | N | N | | | | | | See Below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | N | N | | | | | | See Below | |
| Neonatal Cephalic | | N | N | | | | | | See Below | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | See Below | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | | | | | | See Below | |
| Transvaginal | | N | N | | | | | | See Below | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | See Below | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: Gynecological | | N | N | | | | | | See Below | |
N= new indication; P= previously cleared by FDA; E= added under Appendix A
Additional Comments: Mixed mode operation includes- BM
Applications: Small Parts-(breast, testes & thyroid), abdominal, gynecological-fetal, neonatal cephalic,
transrectal, transvaginal, cardiac, intra-operative-(liver, pancreas, gall bladder, etc.), peripheral vascular.
(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)
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{6}------------------------------------------------
.
・
### Diagnostic Ultrasound Indications for Use Form UST-5561-7.5 (K840540)
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 | | | | | | See Below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | P | P | | | | | | See Below | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)
IE 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)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Radiological Devices 2018 3 255
AAA
00
・
. .
{7}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form UST-556T-7.5 (K840540)
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 | | | | | | See Below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | P | P | | | | | | See Below | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: | | | | | | | | | | |
Ne new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)
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)
(Division Sign-Off) Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
{8}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form UST-556TU-7.5
# (K870916)
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 | | | | | | See Below | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | P | P | | | | | | See Below | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANQTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Herl Rem
(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 083254 510(k) Number _
{9}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form UST-586-5 (K861538)
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) | | N | N | | | | | | See Below | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.)
(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)
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{10}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form UST-5871-5 (K840540)
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 | | | | | | See Below | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | P | P | | | | | | See Below | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, 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)
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
43
{11}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form UST-660-7.5 (K870916)
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 | | | | | | See Below | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
(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)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
. .
ann
44
i 27
{12}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form UST-934N-3.5 (K900805)
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 | | | | | | See Below | |
| Abdominal | | 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 Superficial | | | | | | | | | | |
| Other: Gynecological | | P | P | | | | | | See Below | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
un
(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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices 510(k) Number
{13}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form UST-935N-5 (K900805)
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 | | | | | | See Below | |
| Abdominal | | 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 Superficial | | | | | | | | | | |
| Other: Gynecological | | P | P | | | | | | See Below | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
(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)
(Division Sign-Off) Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
{14}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form UST-944B-3.5 (K870916)
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 | | | | | | See Below | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | P | P | | | | | | See Below | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other: | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
(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)
Ted Kens
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
.
{15}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form UST-945B-5 (K900805)
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 | | | | | | See Below | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | P | P | | | | | | See Below | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: Gynecological | | P | P | | | | | | See Below | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
(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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083254
{16}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form UST-974-5 (K910153)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|-------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | | | | | See Below | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
(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)
Heubolem
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{17}------------------------------------------------
. . .
: ·
### Diagnostic Ultrasound Indications for Use Form UST-981-5 (K900805)
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 | | N | N | | | | | | See Below | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | N | N | | | | | | See Below | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other: Gynecological | | N | N | | | | | | See Below | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
(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)
Prescripti
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 083254 510(k) Number
.
・
50
{18}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form UST-5512U-7.5 (K861538)
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) | | P | P | | | | | | See Below | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | | | | | | See Below | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Convent…
