(4 days)
Not Found
No
The summary describes a standard ultrasound system and its operation, with no mention of AI, ML, or related concepts.
No.
The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis", indicating a diagnostic rather than therapeutic function. The device description also focuses on image generation from reflected sound waves.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" refers to it as a "diagnostic ultrasound system."
No
The device description explicitly states it is a "diagnostic ultrasound system and transducers," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Aloka SSD-3500 Ver. 7.0 is a diagnostic ultrasound system. It uses high-frequency sound waves transmitted into the body to create images and analyze fluid flow within the body.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the body. The diagnostic process happens directly on the patient.
Therefore, this device falls under the category of in vivo diagnostic imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Aloka SSD-3500 Ver. 7.0: "The Aloka SSD-3500 Ver. 7.0, like other Aloka marketed diagnostic ultrasound systems and transducers is indicated for imaging body structures to aid in the diagnosis of disease or abnormality."
Additionally, specific transducers have their own indications:
UST-536: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraoperative (specify) Intraoperative Neurological, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial."
UST-672-5/7.5 (C) / (L): "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraoperative (specify), Transrectal."
UST-676P: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transrectal, Transvaginal."
UST-677P (L) / (T): "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraoperative (specify), Transrectal."
UST-978-3.5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Pediatric."
UST-984-5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal."
UST-990-5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal."
ASU-1003: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal."
ASU-1009: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal."
UST-5293-5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac."
UST-5298: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Pediatric, Cardiac."
UST-5299: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac."
UST-5524-7.5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (specify), Peripheral Vascular."
UST-5542: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (specify), Peripheral Vascular."
UST-5546: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (specify), Peripheral Vascular."
UST-5548: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (specify), Peripheral Vascular."
UST-5710-7.5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (specify)."
UST-9101-7.5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Pediatric."
UST-9102-3.5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal."
UST-9102(U)-3.5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal."
UST-9104-5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraoperative (specify), Neonatal Cephalic."
UST-9112-5: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Transvaginal."
UST-9121: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal."
UST-9123: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal."
UST-9124: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal."
UST-9127: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal."
UST-9128: "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal."
UST-9133: "Intraoperative (specify)."
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
"The Aloka SSD-3500 Ver. 7.0 functions in the same manner as other diagnostic ultrasound devices and its predicate. High frequency sound waves are transmitted into the body by a piezoelectric 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-3500 Ver. 7.0 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow."
Mentions image processing
"processed into an image."
"Color Velocity Imaging" (in tables)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Body structures for general imaging; specified for each transducer where applicable:
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, Musculo-skeletal Conventional, Musculo-skeletal Superficial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Aloka SSD-3500 Ver. 1.0 (K023996)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a sans-serif font.
Public Health Service
FEB 16 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aloka Co., Ltd. % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K060059
Trade Name: Aloka SSD-3500 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: IYN, IYO, and ITX Dated: January 6, 2006 Received: January 9, 2006
Dear Mr. Lehtonen:
This letter corrects our substantially equivalent letter of January 13, 2006.
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). 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 SD-3500 Ultrasound System, as described in your premarket notification:
Image /page/0/Picture/12 description: The image shows a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, there are two lines of text that are difficult to read due to the image quality. Below the letters, the word "Centennial" is written in a cursive font. The entire logo is surrounded by a dotted circle.
cling Puttic . I
1
| UST-536 | UST-5546 |
|---|---|
| UST-672-5/7.5 (C) / (L) | UST-5548 |
| UST-676P | UST-5710-7.5 |
| UST-677P (L) / (T) | UST-9101-7.5 |
| UST-978-3.5 | UST-9102-3.5 |
| UST-984-5 | UST-9102(U)-3.5 |
| UST-990-5 | UST-9104-5 |
| ASU-1003 | UST-9112-5 |
| ASU-1009 | UST-9121 |
| UST-5293-5 | UST-9123 |
| UST-5298 | UST-9124 |
| UST-5299 | UST-9127 |
| UST-5524-7.5 | UST-9128 |
| UST-5542 | UST-9133 |
Transducer Model Number
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
2
Page 2 - Mr. Lehtonen
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (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 (301) 443-6597 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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David C. Lyunn
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
Aloka Co., Ltd.
Model SSD-3500
510(K)
Date: 10/17/05
JAN 1 3 2006
510(k) Summary: Aloka Model SSD-3500 Ver. 7.0 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-3500 Ver. 7.0 diagnostic ultrasound system and transducers. The address is:
10 Fairfield Boulevard Wallingford, CT 06492 Tel: (203) 269-5088 Fax: 203-269-6075 The contact person is: Richard J.Cehovsky, RA/QA Coordinator
The proprietary name is the Aloka SSD-3500 Ver. 7.0 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-3500 Ver. 7.0 and its transducers are substantially equivalent to its predicate; the Aloka SSD-3500 Ver. 1.0 and its transducers.
The Aloka SSD-3500 Ver. 7.0 functions in the same manner as other diagnostic ultrasound devices and its predicate. High frequency sound waves are transmitted into the body by a piezoelectric 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-3500 Ver. 7.0 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The Aloka SSD-3500 Ver. 7.0, like other Aloka marketed diagnostic ultrasound systems and transducers is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
The Aloka SSD-3500 Ver. 7.0 diagnostic ultrasound system and transducers are similar in technological characteristics to Aloka's predicate ultrasound system: SSD-3500 Ver. 1.0 (K023996).
- The SSD-3500 Ver. 7.0 is indicated for the same diagnostic ultrasound applications to . Aloka's ultrasound system: SSD-3500 Ver. 1.0 (K023996).
4
510(k) Summary: Aloka Model SSD-3500 Diagnostic Ultrasound System
- The SSD-3500 Ver. 7.0 has the same gray-scale and Doppler abilities to Aloka's ultrasound . system: SSD-3500 Ver. 1.0 (K023996) .
- . The SSD-3500 Ver. 7.0 uses essentially the same technologies for imaging. Doppler functions and signal processing as the following product currently marketed by Aloka : SSD-3500 Ver. 1.0 - (K023996).
- The SSD-3500 Ver. 7.0 has the same method of use as the following products currently . marketed by Aloka: SSD-3500 - (K023996).
- The SSD-3500 acoustic power output levels are below the maximum levels allowed by the . FDA.
- . The SSD-3500 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka such as the: SSD-3500 -(K023996).
- The patient contact materials used in the SSD-3500 Ver. 7.0 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-3500 Ver. 7.0 complies with electrical and physical safety standards as other products currently marketed by Aloka such as its predicate: SSD-3500 - (K023996).
- Aloka Co., Ltd. Certifies that the SSD-3500 Ver. 7.0 complies with NEMA-UD2:2004 Rev. . 3- (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment), NEMA-UD3: 2004 Rev.2- ( Standard for Real Time Display of Thermal & Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment), and IEC-60601-1-2: 2001 - ( Medical Electrical Equipment Part 1-2: General requirements for Safety-Collateral standard: Electromagnetic compatibility-Requirements and Tests).
5
4.3.1
Diagnostic Ultrasound Indications for Use Form SSD-3500
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (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 | 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 | ||||||||||
| Conventional | P | P | P | P | P | See Below | ||||
| Musculo-skeletal 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, M/CD, B/CD/PWD
Intraoperative 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) Shop
(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number
6
UST-536
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | N | N | N | N | See Below | |||||
| Intraoperative Neurological | N | N | N | N | N | See Below | |||||
| Pediatric | N | N | N | N | N | See Below | |||||
| Small Organ (specify) | N | N | N | N | N | See Below | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | See Below | |||||
| 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, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative: liver, pancreas & gall bladder, Small parts: 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)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060059
7
Diagnostic Ultrasound Indications for Use Form UST-672-517.5 (C) / (L)
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (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 | |||||||||||
| 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, B/PWD, M/CD, B/CD/PWD.
Intra-operative 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 A09)
Ewind A. Jesson
(Division Sign-Off) Division of Reproductive, Abdomi 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (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 | |||||||||||
| 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, B/PWD, M/CD, B/CD/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)
David A. Lipton
(Division Sign-Off) A Division of Reproductive, Abdomin and Radiological Devices 510(k) Number __
9
Diagnostic Ultrasound Indications for Use Form UST-677P (L) / (T)
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | N | N | N | N | See Below | |||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | N | N | N | N | N | See Below | |||||
| 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, B/PWD, M/CD, B/CD/PWD.
Intra-operative 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)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
23
10
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | P | P | See Below | |||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | See Below | |||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| 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, B/PWD, M/CD, B/CD/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)
David G. Ingram
(Division Sign-Off) (Division of Reproductive, Abdomina), 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| 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 | |||||||||||
| 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, B/PWD, M/CD, B/CD/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)
Daniela de ygomm
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices ト!(火) Number ________________________________________________________________________________________________________________________________________________________________
12
Model SSD-3500
Diagnostic Ultrasound Indications for Use Form UST-990-5
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (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 | |||||||||||
| 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, B/PWD, M/CD, B/CD/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 80x109)
Vaind le. Sligerm
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
13
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (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 | ||||||||||
| 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, B/PWD, M/CD, B/CD/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)
்
Chuision of Reproductive, Abdorgina and Radiological Devices > 1 0(k) Number ______________________________________________________________________________________________________________________________________________________________
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | N | N | N | N | N | See Below | ||||
| Abdominal | N | N | N | N | N | 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 | ||||||||||
| 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, B/PWD, M/CD, B/CD/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)
Edmond Ali Seyfarth
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 100(k) Number ________________________________________________________________________________________________________________________________________________________________
15
US1-5293 -3
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | See Below | ||||
| 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, B/PWD, M/CD, B/CD/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)
D
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
Abdominal 159
29
410(k) Number ________________________________________________________________________________________________________________________________________________________________
16
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | See Below | ||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | See Below | ||||
| 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, B/PWD, M/CD, B/CD/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.J09)
David G. Aycock
(Division Sign-Off)
Division of Reproductive. Abdominal and Radiological Devices s 10%) Number ________________________________________________________________________________________________________________________________________________________________
30
17
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 | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | See Below | ||||
| 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, B/PWD, M/CD, B/CD/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)
Climilla. Sisson
(Division Sign-Off) Olvision of Reproductive, Abdogninati and Radiological Devices ් 19tk) Nember ______________________________________________________________________________________________________________________________________________________________
18
UST-5524-7.5
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | P | P | P | P | P | See Below | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | See Below | ||||
| 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, B/PWD, M/CD, B/CD/PWD.
Small parts application includes: 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
(Division Sign-Off) Division of Reproductive. Andofra and Radiological Devices • ﺩﻭﺭﺍﻥ•• : : : : : : : : : : : : : : : : : : : : : : :
lim
19
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 | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color Velocity | ||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| 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 | |||||||||||
| 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, B/PWD, M/CD, B/CD/PWD.
Small parts application includes: 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)
Thinh the dyonm
(Division Sign-Off)
Division of Reproductive, Abdominal.
and Radiological Devices
510(k) Number
K160059
20
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 | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| 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 | |||||||||||
| 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, B/PWD, M/CD, B/CD/PWD.
Small parts application includes: 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)
34
Daniel M. Johnson
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices ි 143k) Number --------------------------------------------------------------------------------------------------------------------------------------------------------------
21
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | | | | | | | | Other
(specify) | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|------------------------|--------------------|-----------------------|
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color Velocity Imaging | | Combined
(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| 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
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, B/PWD, M/CD, B/CD/PWD.
Small parts application includes: 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)
David R. Hyson
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 140jk} Number ________________________________________________________________________________________________________________________________________________________________
રૂટ
22
510(k)
Diagnostic Ultrasound Indications for Use Form UST-5710-7.5
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| 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 | ||||||||||
| 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, B/PWD, M/CD, B/CD/PWD.
Small parts application includes: 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 8012109)
Daniel K. Inouye
(Division Sign-Off) Division of Reproductive. Andomi red Radielogical Devines · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
ina
Kloofs
23
510(k)
Diagnostic Ultrasound Indications for Use Form UST-9101-7.5
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | See Below | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | See Below | ||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| 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, B/PWD, M/CD, B/CD/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)
David H. Lyman
(Division Sign-Off) Division of Reproductive. Abdo on Radiological Devices . . . . . . . . .
Abdominal
K0005
24
Aloka Co., Ltd.
510(k)
Diagnostic Ultrasound Indications for Use Form UST-9102-3.5
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 | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| 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 | ||||||||||
| 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, B/PWD, M/CD, B/CD/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)
David R. Seggern
(Division Sign-Off)
Division of Reproductive, Abdom and Radiological Devices 510(k) Number _
25
Model SSD-3500
510(k)
Diagnostic Ultrasound Indications for Use Form UST-9102(U)-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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| 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 | |||||||||||
| 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, B/PWD, M/CD, B/CD/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)
David A. Hegeman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
Number
6005
26
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (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 | |||||||||||
| 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, B/PWD, M/CD, B/CD/PWD.
Intra-operative 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 Eyaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices ✓
L06005
27
510(k)
Diagnostic Ultrasound Indications for Use Form UST-9112-5
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (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 | |||||||||||
| 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, B/PWD, M/CD, B/CD/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)
David A. Segerson
"Wision Sign-Off) Susion of Reproductive, Abdomit ം Radiological Devices i (){i.) Numbe: __
41
28
Aloka Co., Ltd.
Model SSD-3500
. . . .
510(k)
Diagnostic Ultrasound Indications for Use Form UST-9121
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 | |||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (specify) | Other | |||||||||||
| (specify) | ||||||||||||
| Opthalmic | ||||||||||||
| Fetal | ||||||||||||
| 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 | ||||||||||||
| 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, B/PWD, M/CD, B/CD/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)
Daniel A. Seggern
(Division Sign-Off) Division of Reproductive, Abdog and Padiological Devices :
29
Aloka Co., Ltd.
510(k)
Diagnostic Ultrasound Indications for Use Form UST-9123
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (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 | ||||||||||
| 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, B/PWD, M/CD, B/CD/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)
David A. Leggett
(Division Sign-Off) Division of Reproductive, Abdom and Badinlogical Nevices ちゃ Astrohor
43
30
| Neonatal Cephalic | |||||||
|---|---|---|---|---|---|---|---|
| Adult Cephalic | |||||||
| Cardiac | |||||||
| Transesophageal | |||||||
| Transrectal | |||||||
| Transvaginal | P | P | P | P | P | See Below | |
| 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, B/PWD, M/CD, B/CD/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)
David A. Lypson
Sign-Off)
Son of Reproductive, Abdominal.
Radiological Devices, 100005
Yiki Number
31
510(k)
Diagnostic Ultrasound Indications for Use Form UST-9127
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | N | N | N | N | N | See Below | ||||
| Abdominal | N | N | N | N | N | 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 | ||||||||||
| 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, B/PWD, M/CD, B/CD/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)
David A. Liggon
(Division Sign-Off) Division of Reproductive, Abdo and Padiological Devices 510%) Number ...
32
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (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 | ||||||||||
| 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, B/PWD, M/CD, B/CD/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)
Daniel R. Leggion
(Division Sign-Off)
Division of Reproductive, Abdomina and Radiological Devices , L 119k) Number _
33
| Intraoperative (specify) | N | N | N | N | N | See Below |
|---|---|---|---|---|---|---|
| Intraoperative Neurological | ||||||
| Pediatric | ||||||
| Small Organ (specify) | ||||||
| Neonatal Cephalic | ||||||
| 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, B/PWD, M/CD, B/CD/PWD.
Intra-operative 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)
David A. Ayres
(Division Sign-Offi Division of Reproductive Abdom in: Radiological Devices :: 河北::××1 ;;>><