(134 days)
No
The summary describes a panoramic imaging module for an ultrasound system, focusing on image acquisition and manipulation (pan/zoom/rotate). There is no mention of AI, ML, deep learning, or any related concepts in the provided text. The description of the technology is purely related to extending the field of view and basic image processing.
No
The device is described as an ultrasound imaging system used for diagnostic purposes, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Technos™ ultrasound imaging system, to which the VPan module is added, "is intended to be used by a physician for diagnostic imaging."
No
The device is described as a "Module being added to the Technos™ ultrasound imaging system," indicating it is an addition to existing hardware, not a standalone software device.
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 VPan Module and the Technos™ ultrasound system are used for diagnostic imaging. They create images of internal anatomy using ultrasound waves. This is an in vivo (within the living body) diagnostic method, not an in vitro one.
- Intended Use: The intended use clearly states it's for "diagnostic imaging" in various anatomical applications. It does not mention analyzing biological samples.
Therefore, the VPan Module and the Technos™ ultrasound system are medical devices used for diagnostic imaging, but they do not fall under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.
Product codes
90IYN, 90IYO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal.
Indicated Patient Age Range
Fetal, pediatric, neonatal, adult.
Intended User / Care Setting
Physician
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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) Addition of VPan Module to TechnosMP Ultrasound Imaging System Biosound Esaote
FEB 1 1 2003
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
| Colleen Hittle Densmore, Official Correspondent | ||
|---|---|---|
| 8000 Castleway Drive | ||
| Indianapolis, IN 46250 | ||
| Phone: | (317) 849-1916 | |
| Facsimile: | (317) 577-9070 | |
| Contact Person: | Colleen Hittle Densmore | |
| Date: | January 15, 2003 | |
| 807.92(a)(2) | ||
| Trade Name: | Technos MP Ultrasound Imaging System | |
| (Addition of VPan Module) | ||
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulsed doppler imaging system | 892.1550 |
| Classification Number: | 90IYN | |
| 90IYO | ||
| 807.92(a)(3) | ||
| Predicate Device(s) | ||
| Esaote | AU6 (Technos/TechnosMP) | K014168 |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
1
510(k) Addition of VPan Module to Technos \10 Ultrasound Imaging System Biosound Esaote
807.92(a)(5)
Intended Use(s)
The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.
2
510(k) Summary Addition of VPan Module to
Technos`ll Ultrasound Imaging System Biosound Esaote
Comparison Chart for Substantial Equivalence
| | Acuson
Sequoia 512
FreeStyle Extended
Imaging Software
K022567 | Esaote
Technos/TechnosMp
VPan Module
This Submission |
|--------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Scanning Method | Manual movement of probe
across anatomy to be
imaged | Manual movement of probe
across anatomy to be
imaged |
| Intended Use | Provides panoramic, wide
field-of-view images for
easier orientation of
anatomy & pathology | Provides panoramic, wide
field-of-view images for
easier orientation of
anatomy & pathology |
| Measurements | X, Y Linear distances | X, Y Linear distances |
| Image Manipulation | Pan / zoom / rotate | Pan / zoom / rotate |
| Transducer types | All general imaging
transducers | Convex / Linear / Phased
Array |
| Image Format | Spliced B-mode | Spliced B-mode |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2003
Ms. Colleen Densmore Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive INDIANAPOLIS IN 46250 Re: K023255
Trade/Device Name: Technos MP Ultrasound Imaging System Addition of VPan Module Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYN and IYO Dated: January 15, 2003 Received: January 16, 2003
Dear Ms. Densmore:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): 1023 255-8
Device Name:
Indications for Use:
The VPan (View Panoramic) Module is being added to the TechnosMP ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
The Technost 10 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.
Prescription Use
David A. Seayom
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)