(140 days)
Diagnostic Ultrasound imaging of the human body as follows: Fetal, Abdominal, Intra-Operative, Intra-Operative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Transrectal, Transvaginal, Musculo-Skeletal Conventional, Peripheral Vessel, Laparoscopic.
The Aloka SSD-900 diagnostic ultrasound system. The SSD-900 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 slice images.
This 510(k) summary for the Aloka SSD-900 diagnostic ultrasound system and its associated transducers (K983879) primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing performance against specific acceptance criteria through clinical studies.
Therefore, the document does not contain the detailed clinical study information typically found for devices requiring performance metrics, ground truth establishment, or human-AI comparison. Instead, the "study" is a comparison to predicate devices, asserting similar technological characteristics, indications for use, gray-scale abilities, signal processing, method of use, acoustic power output, and safety standards.
Here's an attempt to structure the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or inferential due to the nature of a 510(k) substantial equivalence submission for an ultrasound system:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for substantial equivalence of a diagnostic ultrasound system (Aloka SSD-900) and its transducers, the "acceptance criteria" are not defined as specific quantitative performance metrics from a clinical study. Instead, the acceptance criteria are met by demonstrating the device is substantially equivalent to predicate devices in terms of:
| Acceptance Criterion (Implicit in Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Intended Use: Same indications as predicate devices. | "The SSD-900 is indicated for the same diagnostic ultrasound applications as other products currently marketed by Aloka and others." Also, specific Indications for Use tables are provided for the system and each transducer, confirming various clinical applications (e.g., Fetal, Abdominal, Small Organ, Cardiac, Transrectal, Intra-Operative, etc.) and modes of operation (B-mode, M-mode, A-mode, PWD, CWD, Color Doppler, Amplitude Doppler, CVI, Combined). |
| Technological Characteristics: Similar to predicate devices. | "The SSD-900 uses essentially the same technologies for imaging and signal processing as other products currently marketed by Aloka and others." |
| Gray-scale Abilities: Equivalent to predicate devices. | "The SSD-900 has the same gray-scale abilities as other products currently offered by Aloka and others." |
| Method of Use: Similar to predicate devices. | "The SSD-900 has the same method of use as other products currently marketed by Aloka and others." |
| Acoustic Power Output: Below FDA maximum levels. | "The SSD-900 acoustic power output levels are below the maximum levels allowed by the FDA." (Requires post-clearance special report). |
| Quality Assurance: Subject to the same QA systems. | "The SSD-900 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka." |
| Patient Contact Materials: Safe for application. | "The patient contact materials used in the probes for the SSD-900 have been evaluated and found to be safe for this application." |
| Safety Standards: Complies with electrical and physical safety. | "The SSD-900 complies with the same electrical and physical safety standards as other products currently marketed by Aloka." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission does not describe a clinical performance study with a dedicated "test set" in the context of algorithm evaluation. The "test" is the comparison against predicate devices and adherence to safety standards.
- Data Provenance: Not applicable for a traditional clinical study test set. The submission relies on existing knowledge of predicate devices and general standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No "ground truth" establishment by experts on a test set is described for performance evaluation. The "ground truth" for substantial equivalence is regulatory compliance and comparison to legally marketed devices.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no described test set requiring expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The Aloka SSD-900 is a diagnostic ultrasound system from 1999, and the concept of AI assistance in diagnostic imaging, especially for regulatory submissions, was nascent or non-existent at that time for such devices.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: No, this device is an ultrasound system, not an AI algorithm. Its performance is inherent in its imaging capabilities assisted by a human operator, not a standalone AI function.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is primarily regulatory compliance, technical specifications, and the established safety and effectiveness of predicate devices. The submission asserts the new device meets current safety standards (e.g., FDA acoustic power limits, electrical safety) and functions equivalently to already cleared devices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document pertains to an ultrasound hardware system, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
In summary: This 510(k) submission demonstrates substantial equivalence for the Aloka SSD-900 diagnostic ultrasound system. It is a traditional medical device submission based on comparison to predicate devices and adherence to relevant safety and performance standards for ultrasound equipment, rather than a submission for an AI-powered device requiring clinical studies with specific performance metrics and ground truth establishment against expert consensus or pathology.
{0}------------------------------------------------
3/22/99
510(k) SUMMARY
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-900 diagnostic ultrasound system. The address is:
10 Fairfield Boulevard Wallingford, CT. 06492
The contact person is Paul D. Smolenski, Manager, Quality and Regulatory Affairs.
The proprietary name for the transducer is the Aloka SSD-900 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 ITX - Transducer, Ultrasonic, Diagnostic 90 IYO - Ultrasonic Pulsed Echo Imaging System and Accessories
The above as stated in 21 CFR, part 892.1570, and 892.1560 have been classified as regulatory Class II.
The Aloka SSD-900 is substantially equivalent to several previously marketed diagnostic ultrasound systems such as the Aloka SSD-1400.
The SSD-900 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 slice images.
The SSD-900, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
The Aloka SSD-900 diagnostic ultrasound system with gray-scale imaging modalities is similar in technological characteristics to ultrasound systems marketed by Aloka and others:
- The SSD-900 is indicated for the same diagnostic ultrasound applications as other . products currently marketed by Aloka and others.
{1}------------------------------------------------
- The SSD-900 has the same gray-scale abilities as other products currently offered by . Aloka and others.
- The SSD-900 uses essentially the same technologies for imaging and signal processing . as other products currently marketed by Aloka and others.
- The SSD-900 has the same method of use as other products currently marketed by . Aloka and others.
- The SSD-900 acoustic power output levels are below the maximum levels allowed by . the FDA.
- The SSD-900 is subjected to the same Quality Assurance systems in development and . production as other products currently marketed by Aloka.
- The patient contact materials used in the probes for the SSD-900 have been evaluated . and found to be safe for this application.
- The SSD-900 complies with the same electrical and physical safety standards as other . products currently marketed by Aloka.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
Public Health Service
MAR 2 2 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shoichi Nakai General Manager Aloka Co., Ltd. 10 Fairfield Boulevard Wallingford, CT 06492-7502
Re: K983879
Aloka SSD-900 Diagnostic Ultrasound System Regulatory Class: II/21 CFR 892.1560/21 CFR 892.1570 Product Code: 90 IYO/90 ITX Dated: February 1, 1999 Received: February 2, 1999
Dear Mr. Nakai:
We have reviewed your 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-900 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| ASU-35WL-10 | ASU-36WL-10 | ASU-35-3 | ASU-66 | ASU-64 |
|---|---|---|---|---|
| UST-5524-7.5 | UST-5536-7.5 | UST-579T-7.5 | UST-670P-5 | UST-670P-5 |
| UST-979-3.5 | UST-984P-5 | UST-987-7.5 | UST-9116P-5 | UST-995-7.5 |
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 (OS) 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.
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 investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 이상 인물
14.81 - 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1.
{3}------------------------------------------------
Page 2 - Shoichi Nakai
This determination of substantial equivalence is granted on the 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".
If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D. at (301) 594-1212.
Sincerely vours.
David A. Seymore
CAPT Daniel G. 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
Enclosures
{4}------------------------------------------------
K 983879
510(k) Number (if known): Device Name:
..............................................................................................................................................................................
unknown at submission Aloka SSD-900 Diagnostic Ultrasound System
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | CVI | Combined | Other |
| Opthalmic | ||||||||||
| Fetal | ✓ | ✓ | B/M | |||||||
| Abdominal | ✓ | ✓ | ✓ | B/M | ||||||
| Intra-Operative | ✓ | ✓ | B/M | |||||||
| Intra-OperativeNeurological | ✓ | ✓ | B/M | |||||||
| Pediatric | ✓ | ✓ | B/M | |||||||
| Small Organ | ✓ | ✓ | B/M | |||||||
| Neonatal Cephalic | ✓ | ✓ | B/M | |||||||
| Adult Cephalic | ✓ | ✓ | B/M | |||||||
| Cardiac Adult | ✓ | ✓ | B/M | |||||||
| Cardiac Pediatric | ✓ | ✓ | B/M | |||||||
| Transesophageal | ||||||||||
| Transrectal | ✓ | ✓ | B/M | |||||||
| Transvaginal | ✓ | ✓ | B/M | |||||||
| Transuretheral | ||||||||||
| Musculo-SkeletalConventional | ✓ | ✓ | B/M | |||||||
| Musculo-skeletalSuperficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | ✓ | ✓ | B/M | |||||||
| Laparoscopic | ✓ | ✓ | B/M |
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (O
Prescription Use (Per 21 CFR 801.109)
David li. Begom
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Page 1 of 16
{5}------------------------------------------------
963879
Page 2 of 16
Ultrasound Device Indications Statement
510(k) Number (if known): Device Name:
:
unknown at submission ASU-35WL-10
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | A | B | M | PWD | CWD | Color | Amplitude | CVI | Combined | Other | |
| Application | Doppler | Doppler | |||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-Operative | |||||||||||
| Intra-Operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | ✓ | ✓ | |||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Transesophageal | |||||||||||
| fransrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Musculo-Skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Intraluminal | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic |
Other Indications or Modes:
Small Organ Applications:
Breast, Testes, Thyroid
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
David L. Siegmann
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number
Prescription Use (Per 21 CFR 801.109)
21
{6}------------------------------------------------
K983879
Ultrasound Device Indications Statement
Page 3 of 16
510(k) Number (if known): Device Name:
unknown at submission ASU-36WL-10
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative | ||||||||||
| Intra-Operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ✓ | ✓ | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Transesophageal | ||||||||||
| ransrectal | ||||||||||
| Transvaginal | ||||||||||
| Transuretheral | ||||||||||
| Musculo-Skeletal | ✓ | ✓ | ||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes:
Small Organ Applications:
Breast, Testes, Thyroid
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluatition (ODE)
Ehrich G. Segism
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
{7}------------------------------------------------
Page 4 of 16
unknown at submission 510(k) Number (if known): ASU-35-3 Device Name:
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | A | B | M | PWD | CWD | Color | Amplitude | CVI | Combined | Other |
| Application | Doppler | Doppler | ||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative | ||||||||||
| Intra-Operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ✓ | ✓ | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ✓ | ✓ | ||||||||
| Cardiac Pediatric | ✓ | ✓ | ||||||||
| Transesophageal | ||||||||||
| ransrectal | ||||||||||
| Transvaginal | ||||||||||
| Transuretheral | ||||||||||
| Musculo-Skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes:
Small Parts: Breast, Testes, Thyroid
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
David C. Lygum
(Division Sign-Off)
( Division of Reproductive, Abdominal, ENT, and Radiological Devices and Radiological Devices and Radiological Devices 510(k) Number
{8}------------------------------------------------
Page 5 of 16
510(k) Number (if known): ASU-66 Device Name:
unknown at submission
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | CVI | Combined | Other | |
| Opthalmic | |||||||||||
| Fetal | ✓ | ✓ | |||||||||
| Abdominal | |||||||||||
| Intra-Operative | |||||||||||
| Intra-Operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Transesophageal | |||||||||||
| transrectal | |||||||||||
| Transvaginal | ✓ | ✓ | |||||||||
| Transuretheral | |||||||||||
| Musculo-Skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Intraluminal | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic |
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
Vinit C. Segmm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)
- ..
{9}------------------------------------------------
K9653879
Page 6 of 16
unknown at submission 510(k) Number (if known): Device Name: ASU-64
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative | ||||||||||
| Intra-Operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Transesophageal | ✓ | |||||||||
| Transrectal | ✓ | |||||||||
| Transvaginal | ||||||||||
| Transuretheral | ||||||||||
| Musculo-Skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
Elnit G. Sealing
(Division Sign-Off) ( Division of Reproductive, Abdominal, ENT)
and Radiological Devices and Radiological Dev 510(k) Number
Prescription Use (Per 21 CFR 801.109)
.
{10}------------------------------------------------
Page 7 of 16
510(k) Number (if known): Device Name:
unknown at submission UST-5524-7.5
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-Operative | |||||||||||
| Intra-Operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | ✓ | ✓ | B/M | ||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Transesophageal | |||||||||||
| fransrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Musculo-Skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Intraluminal | |||||||||||
| Peripheral Vessel | ✓ | ✓ | B/M | ||||||||
| Laparoscopic |
Other Indications or Modes:
Small Organ Applications:
Breast, Testes, Thyroid
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluatition (ODE)
Emil C. Hegmann
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT
and Radiological Devices and Radiological Device 510(k) Number
{11}------------------------------------------------
510(k) Number (if known): unknown at submission UST-5536-7.5 Transducer Device Name:
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | CVI | Combined | Other |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative | ||||||||||
| Intra-Operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transuretheral | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | ✓ | ✓ | ||||||||
| Laparoscopic | ✓ | ✓ | B/M |
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
Gland G. Siggm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Page 8 of 16
1
{12}------------------------------------------------
K9835879
Page 9 of 16
510(k) Number (if known): unknown at submission UST-579T-7.5 Device Name:
ﺴﻌﻴﺪ
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative | B/M | |||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | B/M | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Transesophageal/transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transuretheral | ||||||||||
| Musculo-Skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | B/M | |||||||||
| Laparoscopic |
Combined Modes: B/M, B/PWD Other Indications or Modes:
Intraoperative Applications: Small Organ Applications:
Abdominal (such as liver, pancreas, gall bladder) Breast, Testes, Thyroid
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
Ehrid C. Szyrm
(Division Sign-Off)
(Production Sigli-Off)
Division of Reproductive, Abdominal, EN and Radiological Reproduct
and Radiological Devi
Surgical Devices
510(k) Number K98387
{13}------------------------------------------------
K9833879
Page 10 of 16
510(k) Number (if known): Device Name:
unknown at submission UST-672-5/7.5
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | CVI | Combined | Other | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | ✓ | ✓ | B/M | ||||||||
| Intra-Operative | ✓ | ||||||||||
| Intra-Operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Transesophageal | |||||||||||
| 'ransrectal | ✓ | ✓ | B/M | ||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Musculo-Skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Intraluminal | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic |
Other Indications or Modes:
Intraoperative Applications:
Abdominal (such as liver, pancreas, gall bladder)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
Uminh C. Nguyen
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT,
and Radiological Deyices, Abdominal, ENT, 510(k) Number
{14}------------------------------------------------
510(k) Number (if known): Device Name:
unknown at submission UST-670P-5
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| Clinical Application | MODES of OPERATION | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other | |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative | ||||||||||
| Intra-Operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ✓ | ✓ | B/M | |||||||
| Transvaginal | ✓ | ✓ | B/M | |||||||
| Transuretheral | ||||||||||
| Musculo-Skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
Laind L. Pearson
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number
rescription Use (Per 21 CFR 801.109)
t
Page 11 of 16
{15}------------------------------------------------
Page 12 of 16
510(k) Number (if known): unknown at submission UST-979-3.5 Device Name:
Fill our one form for each ultrasound system and transducer
Indications for Use: Diagnostic Ultrasound imaging of the human body as follows:
| MODES of OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | A | B | M | PWD | CWD | Color | Amplitude | CVI | Combined | Other |
| Application | Doppler | Doppler | ||||||||
| Opthalmic | ||||||||||
| Fetal | > | > | B/M | |||||||
| Abdominal | > | V | BM | |||||||
| Intra-Operative | ||||||||||
| Intra-Operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | > | > | B/M | |||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Transesophageal | ||||||||||
| ransrectal | ||||||||||
| Transvaginal | ||||||||||
| Transuretheral | ||||||||||
| Musculo-Skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
David A. Watson
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number
{16}------------------------------------------------
Page 13 of 16
510(k) Number (if known): unknown at submission UST-984P-5 Device Name:
्
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | CVI | Combined | Other |
| Opthalmic | ||||||||||
| Fetal | ✓ | ✓ | B/M | |||||||
| Abdominal | ||||||||||
| Intra-Operative | ||||||||||
| Intra-Operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Transesophagealransrectal | ||||||||||
| Transvaginal | ✓ | ✓ | B/M | |||||||
| Transuretheral | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluatition (ODE)
Daniel A. Segerson
ive, Abdominal,
{17}------------------------------------------------
Page 14 of 16
510(k) Number (if known): unknown at submission UST-987-7.5 Device Name:
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | CVI | Combined | Other | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-Operative | ✓ | ✓ | B/M | ||||||||
| Intra-OperativeNeurological | ✓ | ✓ | B/M | ||||||||
| Pediatric | |||||||||||
| Small Organ | ✓ | ✓ | B/M | ||||||||
| Neonatal Cephalic | ✓ | ✓ | B/M | ||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Musculo-SkeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Intraluminal | |||||||||||
| Peripheral VesselLaparoscopic |
Other Indications or Modes:
Intraoperative Applications: Small Organ Applications:
Neurological, Abdominal (such as liver, pancreas, gall bladder) Breast, Testes, Thyroid
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Øffice of Device Evaluatition (ODE)
Yamil h. Nayam
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev. 510(k) Number
{18}------------------------------------------------
Page 15 of 16
510(k) Number (if known): Device Name:
ﮯ ﺳﯿﺮﺱ
unknown at submission UST-9116P-5
Fill our one form for each ultrasound system and transducer
Indications for Use: Diagnostic Ultrasound imaging of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | CVI | Combined | Other |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative | ✓ | ✓ | B/M | |||||||
| Intra-Operative | ✓ | ✓ | B/M | |||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Transesophageal | ||||||||||
| transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transuretheral | ||||||||||
| Musculo-Skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Intraluminal | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic |
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluatition (ODE)
Simil C. Lezman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number K983879
{19}------------------------------------------------
Page 16 of 16
510(k) Number (if known): unknown at submission UST-995-7.5 Device Name:
Fill our one form for each ultrasound system and transducer
Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:
| MODES of OPERATION | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | CVI | Combined | Other | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-Operative | ✓ | ✓ | B/M | ||||||||
| Intra-Operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Musculo-Skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Intraluminal | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic |
Combined Modes: B/M,B/PWD Other Indications or Modes:
Intraoperative Applications:
Abdominal (such as liver, pancreas, gall bladder)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluatition (ODE)
Clint C. Sazom
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.