(15 days)
Toshiba Power Vision, H.P. Sonos 5500, Vingmed (G.E.) System V, ATL HDI-5000
No
The document describes standard ultrasound technology and signal processing without mentioning AI, ML, or related concepts.
No
The device is explicitly described as a "diagnostic ultrasound system" used for "imaging body structures and flowing blood to aid in the diagnosis of disease or abnormality," which means its primary function is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for imaging body structures and flowing blood to aid in the diagnosis of disease or abnormality" and is referred to multiple times as a "diagnostic ultrasound system" or "diagnostic ultrasonic scanner."
No
The device description explicitly states it is a "diagnostic ultrasound system" that uses a "piezo-electric transducer" to transmit and receive sound waves, which are hardware components.
Based on the provided text, the Aloka SSD-5500 is not an IVD (In Vitro Diagnostic) device.
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 or other conditions.
- Aloka SSD-5500 Function: The text clearly describes the Aloka SSD-5500 as a diagnostic ultrasound system that uses sound waves transmitted into the body to create images of internal structures and blood flow. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- No Mention of Samples: The description focuses on the interaction of ultrasound waves with the body and the processing of reflected signals. There is no mention of analyzing samples taken from the patient.
Therefore, the Aloka SSD-5500 is a diagnostic imaging device that operates in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aloka SSD-5500 is a Track 3 system. Its maximum acoustic outputs are below the pre-amendments upper limits and it conforms to the "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment". The maximum thermal index is below 6.0. Depending on the probe, the Aloka SSD-5500 may be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Trauma and Surgical applications, The Aloka SSD-5500 is not indicated for ophthalmic applications and there are no other contraindication known.
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, 90 ITX, 90 IYO
Device Description
The Aloka SSD-5500 diagnostic ultrasound system. The Aloka SSD-5500 is an all-digital diagnostic ultrasonic scanner with a digital beamformer supporting grav scale, spectral Doppler and Color Flow imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Trauma and Surgical applications including: Fetal, Abdominal, Intraoperative (liver, pancreas and gall bladder), Intraoperative Neurological, Pediatric, Small Organ (breast, testes and thyroid), Neonatal Cephalic, Adult Cephalic, 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-2000, Aloka SSD-1700, K963616, K954022
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.
Toshiba Power Vision, H.P. Sonos 5500, Vingmed (G.E.) System V, ATL HDI-5000
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
510(k) SUMMARY
This summary statement complies with 21 CFR, section 807.92 as amended March 14, I 995 :
This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-5500 diagnostic ultrasound system. The address is:
Aloka Co., Ltd. 10 Fairfield Boulevard Wallingford, CT. 06492
The contact person is Christopher M. Bohl, Technical Product Manager.
The proprietary name for the system is the Aloka SSD-5500 diagnostic ultrasound system. The common name for this type of device is a diagnostic ultrasound system and associated accessories.
The items in this submission are covered under the following classifications:
-
90 IYN Ultrasonic, Pulsed Doppler Imaging System
90 ITX - Transducer, Ultrasonic, Diagnostic -
90 IYO Ultrasonic Pulsed Echo Imaging System and Accessories
The above as stated in 21 CFR, part 892.1550 and 892.1560 have been classified as regulatory Class II.
The Aloka SSD-5500 is substantially equivalent to several previously marketed diagnostic ultrasound systems such as the Aloka SSD-2000. Aloka SSD-1700. Toshiba Power Vision, H.P. Sonos 5500, Vingmed (G.E.) System V and ATL HDI-5000
The SSD-5500 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is processed into two-dimensional images. The reflected ultrasound energy is also processed using Doppler principals and displays moving blood as a spectrum or as a color-coded real time two-dimensional image.
The SSD-5500, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures and flowing blood to aid in the diagnosis of disease or abnormality.
The Aloka SSD-5500 diagnostic ultrasound system with gray-scale, spectral Doppler and color flow mapping imaging modes is similar in technological characteristics to ultrasound systems marketed by Aloka and others:
- The SSD-5500 is indicated for the same diagnostic ultrasound applications as other . products currently marketed by Aloka and others.
- The SSD-5500 has the same gray-scale, spectral Doppler and Color Flow Mapping . abilities as other products currently offered by Aloka and others.
1
- The SSD-5500 uses similar technologies for imaging and signal processing as other . products currently marketed by Aloka and others.
- The SSD-5500 has the same method of use as other products currently marketed by . Aloka and others.
- The SSD-5500 acoustic power output levels are below the maximum levels allowed by . the FDA.
- Aloka subjects the SSD-5500 to the same Quality Assurance systems in development . and production as other products currently marketed.
- The patient contact materials used in the probes for the SSD-5500 have been . evaluated and found to be safe for their intended application.
- The SSD-5500 complies with the same electrical and physical safety standards as other . products currently marketed by Aloka.
BASIC INFORMATION 4.2
4.2.1 Manufacturer's Name
The Aloka SSD-5500 manufactured by:
Aloka Co., Ltd. 6-22-1 Mure, Mitaka-shi Tokyo 181 Japan
Initial Distributor 4.2.2
The initial distributor for Aloka products is:
Aloka Co., Ltd. 10 Fairfield Blvd. Wallingford, CT 06492
4.2.3 Device Name
The name of the device is the Aloka SSD-5500 diagnostic ultrasound system.
4.2.4 Common Name
The SSD-5500 is commonly known as a diagnostic ultrasound system.
4.2.5 Classification
The Aloka SSD-5500 may be classified as 90 IYO-Ultrasonic Pulsed Imaging System and 90 IYN-Ultrasonic Pulsed Doppler Imaging System. The associated transducers are classified as 90 ITX - Diagnostic Ultrasound Transducer.
The above as stated in 21 CFR, part 892.1570 and 892.1570 and 892.1560, have been classified as regulatory Class II.
4.2.6 Establishment Registration Number
The establishment registration number for Aloka America is 1222669
2
4.2.7 514 Performance Standards
There are no 514-performance standards for diagnostic ultrasound equipment.
4.2.8 Special Controls
Special controls for diagnostic ultrasound consist of the "Special Controls Report" consisting primarily of final acoustic output and final labeling. The Special Controls report for the product described in this submission will be submitted at a future date and prior to first customer shipment.
Prescription Status 4.2.9
All diagnostic ultrasound systems are prescription devices. The prescription statement appears in the user's manuals.
4.2.10 Manufacturing Location
Aloka in Japan manufactures the SSD-5500.
4.2.11 Sterilization Site
None of the products described in this submission are provided sterile.
4.2.12 Reason for Submission
The SSD-5500 is a new diagnostic ultrasound system.
4.2.13 Track (1 or 3)
The SSD-5500 is a Track 3 system.
INDICATIONS FOR USE 4.3
INDICATIONS FOR USE OF THE SSD-5500 4.3.1
The subject Aloka SSD-5500 is an all-digital diagnostic ultrasonic scanner with a digital beamformer supporting grav scale, spectral Doppler and Color Flow imaging. It is based upon and substantially equivalent to the Aloka SSD-1700 and SSD-2000 systems, which received clearance for market under K963616 and K954022. The SSD-5500 is also equivalent to other high performance digital beamforming systems such as the Toshiba PowerVision. ATL HDI-5000. H.P. Sonos 5500 and Vingmed (G.E.) System V.
The Aloka SSD-5500 is a Track 3 system. Its maximum acoustic outputs are below the pre-amendments upper limits and it conforms to the "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment". The maximum thermal index is below 6.0. Depending on the probe, the Aloka SSD-5500 may be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Trauma and Surgical applications,
The Aloka SSD-5500 is not indicated for ophthalmic applications and there are no other contraindication known.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1999
Aloka Co., Ltd. C/o Donald J. Sherratt Intertek Testing Services 70 Codman Hill Road Boxborough, MA 01719
K992663 Re:
Aloka SSD 5500 Dated: August 6, 1999 Received: August 9, 1999 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Sherratt:
We have reviewed vour Section 510/k) 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 SSD 5500, as described in your premarket notification:
Transducer Model Number
| UST-5268P-5 | UST-5286-2.5 |
|---|---|
| UST-5536-7.5 | UST-5539-7.5 |
| UST-5713T | UST-672-5/7.5 |
| UST-675P | UST-9119 |
| UST-987-7.5 | UST-995-7.5 |
| UST-9118 |
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page -2- Mr. Sherratt
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
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.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
5
Page – 3- Mr. Sherratt
If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D. at (301) 594-1212.
Sincerely yours,
CAPT Daniel Schultz, M.D.
Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Diagnostic Ultrasound Indications for Use Form SSD-2500
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | √ | √ | √ | √ | √ | See Below | ||||
| Abdominal | √ | √ | √ | √ | √ | See Below | ||||
| Intraoperative (specify) | √ | √ | √ | √ | √ | See Below | ||||
| Intraoperative Neurological | √ | √ | √ | √ | √ | See Below | ||||
| Pediatric | √ | √ | √ | √ | √ | See Below | ||||
| Small Organ (specify) | √ | √ | √ | √ | √ | See Below | ||||
| Neonatal Cephalic | √ | √ | √ | √ | √ | See Below | ||||
| Adult Cephalic | √ | √ | √ | √ | √ | See Below | ||||
| Cardiac | √ | √ | √ | √ | √ | √ | See Below | |||
| Transesophageal | √ | √ | √ | √ | √ | See Below | ||||
| Transrectal | √ | √ | √ | √ | √ | See Below | ||||
| Transvaginal | √ | √ | √ | √ | √ | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | √ | √ | √ | √ | √ | See Below | ||||
| Laparoscopic | √ | √ | √ | √ | √ | See Below | ||||
| Musculo-skeletal | ||||||||||
| Conventional | √ | √ | √ | √ | √ | See Below | ||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications include liver, pancreas and gall bladder. Small 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)
David Warren
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K992663
7
Diagnostic Ultrasound Indications for Use Form UST-5268P-5
| 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) | √ | √ | √ | √ | √ | See Below | ||||
| Intraoperative Neurological | √ | √ | √ | • √ | √ | See Below | ||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | √ | √ | √ | √ | √ | See Below | ||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode operation includes BM, B/Bflow/PWD. The transducer has applications in Neurological Burr Hole and abdominal surgical applications such 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)
Daniel W. Ingram
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) " Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number Ky 9
8
Diagnostic Ultrasound Indications for Use Form UST-5286-2.5
| 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 | √ | √ | √ | √ | √ | √ | See Below | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
:.10(k) Number K992663
9
Diagnostic Ultrasound Indications for Use Form UST-5536-7.5
| 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 | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | √ | √ | √ | √ | √ | See Below | |||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
signature
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 65 510(k) Number ...
10
Diagnostic Ultrasound Indications for Use Form UST-5539-7.5
| 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) | √ | √ | √ | √ | √ | √ | See Below | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | √ | √ | √ | √ | √ | √ | See Below | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | √ | √ | √ | √ | √ | √ | See Below | |||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K 992663
। ୧
11
Diagnostic Ultrasound Indications for Use Form
UST-5713T
| Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (specify) | |||||||||
| Opthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | √ | √ | √ | √ | √ | See Below | |||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | √ | √ | √ | √ | √ | See Below | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | √ | √ | √ | √ | √ | See Below | |||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications for this transducer include liver, pancreas and gall bladder. Small Organ 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)
Ernest L. Deigner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number_
12
Diagnostic Ultrasound Indications for Use Form UST-672-517.5
| 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) | √ | √ | √ | √ | √ | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | √ | √ | √ | √ | √ | See Below | ||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications include abdominal, bladder, pancreas and gall bladder.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Leonard H. Lawson
(Division Sign-Off) 1 Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K992663
13
Diagnostic Ultrasound Indications for Use Form UST-675P
| 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 | √ | √ | √ | √ | √ | See Below | ||||
| Transvaginal | √ | √ | √ | √ | √ | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Prescription Use (Per 21 CFR 801.109)
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Emil Anderson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number _K
14
Diagnostic Ultrasound Indications for Use Form UST-9118
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | √ | √ | √ | √ | √ | See Below | ||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | √ | √ | √ | √ | √ | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Prescription Use (Per 21 CFR 801.109)
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Evelyn L. Taylor
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
15
Diagnostic Ultrasound Indications for Use Form UST-9119
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | √ | √ | √ | √ | √ | See Below | ||||
| Abdominal | √ | √ | √ | √ | √ | 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 | See Below | |||||||||
| Other | √ | √ | √ | √ | √ | See Below |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. The Other Addition of this transducer is in gynecological imaging of the female pelvis, uterus and ovaries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
(Division Sign-Off)/ Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K992663
Prescription Use (Per 21 CFR 801.109)
16
Diagnostic Ultrasound Indications for Use Form
UST-987-7.5
| 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) | √ | √ | √ | √ | √ | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | √ | √ | √ | √ | √ | See Below | ||||
| Neonatal Cephalic | √ | √ | √ | √ | √ | See Below | ||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | √ | √ | √ | √ | √ | See Below | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications for this transducer include liver, pancreas and gall bladder. Small Organ 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)
Karol L. Kregler
22
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number K992663
17
Diagnostic Ultrasound Indications for Use Form UST-995-7.5
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | √ | √ | √ | | √ | √ | | See Below | |
| Intraoperative Neurological | | | | | . | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | √ | √ | √ | | √ | √ | | See Below | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | √ | √ | √ | | √ | √ | | See Below | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments; Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications for this transducer include liver, pancreas and gall bladder. Small Organ 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)
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .