(80 days)
No
The description focuses on 3D rendering and image manipulation, not AI/ML algorithms for analysis or interpretation.
No.
The device is for medical image management, display, and manipulation, and does not provide therapeutic treatment.
No
The device is described as an image management system that displays and manipulates medical images, including 3D rendering of ultrasound data. While it processes images from a "diagnostic ultrasound scanning procedure," the device itself does not perform diagnosis; it simply manages and displays the images for review.
Yes
The device is described as a "software component" and a "software module" that performs image management and manipulation functions. While it processes data from ultrasound systems (hardware), the device itself, as described in the summary, is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "acceptance, transfer, display, storage and digital processing of medical images." It also mentions displaying and manipulating a 3D volume image created from diagnostic ultrasound data. None of these activities involve testing samples taken from the human body (like blood, urine, or tissue) to diagnose disease or other conditions.
- Device Description: The description focuses on the software's ability to store, render, display, and manipulate ultrasound images. This is consistent with medical imaging management and visualization, not in vitro diagnostics.
- Lack of IVD-related activities: There is no mention of analyzing biological samples, performing chemical or biological tests, or providing diagnostic information based on such tests.
The device is a medical image management and visualization system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The DICOMIT Dicom Image Manager medical image management system is intended for acceptance, transfer, display, storage and digital processing of medical images. The software component provides functions for performing operations related to image manipulation.
The "3D ROI" software option enables the device to display and manipulate an adjunctive 3D volume image created with data from a diagnostic ultrasound scanning procedure.
Product codes
IYO
Device Description
The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
4/16/99
Page A - 4 510(k) Notification DICOM IMAGE MANAGER - Addition of 3D Visualization Software Module 510 (k) SUMMARY
This following summary is provided as part of this Premarket Notification in compliance with and based on the format set forth in the Final Rule as published in the Federal Register, December 14, 1994. (See 21 CFR § 807.92)
(1) Submitters Name / Contact Person:
Dicomit Imaging Systems Corp. 75 East Beaver Creek Road, Unit 9 Richmond Hill, Ontario Canada L4B 1K6
| Contact Person: | Terry Callahan |
|---|---|
| Tel.: (905) 886-9496 | |
| Fax: (905) 886-2109 | |
| E-mail: tcallahan@dicomit.com |
January 22, 1999 Date prepared:
(2) Name of device:
| Trade Name: | Dicom Image Manager™ "3D ROI™" |
|---|---|
| Common Name: | 3D Visualization Module |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System |
(3) Identification of predicate devices:
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Dicomit Imaging Systems Corp. | Dicom Image Manager | K951925 |
| Advanced Technology Labs | ATL HDI 3000/5000 Ultrasound systems | K961459 |
| General Electric Medical Systems | GE LOGIQ 700 Ultrasound system | K964617 |
(4) Description of the device:
The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.
1
Page A - 5 510(k) Notification DICOM IMAGE MANAGER - Addition of 3D Visualization Software Module
(5) A statement of the intended use of the device:
The DICOMIT Dicom Image Manager medical image management system is intended for acceptance, transfer, display, storage and digital processing of medical images. The software component provides functions for performing operations related to image manipulation.
The "3D ROI" software option enables the device to display and manipulate an adjunctive 3D volume image created with data from a diagnostic ultrasound scanning procedure.
(6) Predicate Device Comparison:
The DICOMIT Dicom Image Manager - with 3D Visualization Software Module is substantially equivalent to similar features in the predicate devices and has the same intended uses and technological characteristics as the predicate devices.
The DICOMIT system and the predicate devices all use standard ultrasound system probes. All systems acquire multiple sequential images scanned in a "freehand" manner by the user without special positioning devices or position sensors.
The resulting sequential images are stored in the ultrasound system memory commonly called "Cine" or "Cine Loop". On all three systems the 3D volume images are rendered using the individual B-mode scan images acquired from the "freehand" scan.
The DICOMIT Dicom Image Manager - with 3D Visualization Software Module creates a 3D volume image in the same manner as the predicate devices described in this submission.
2
Image /page/2/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. Inside the circle is an image of an abstract eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 1999
Terry Callahan President Dicomit Imaging Systems Corp. 75 East Beaver Creek Rd., Unit 9 Richmond Hill. Ontario Canada L4B 1K6
Re:
K990248 DICOM Image Manager, 3D Visualization Option "3D ROI" Dated: January 22, 1999 Received: January 26, 1999 Regulatory class: II 21 CFR 892_1560/Procode: 90 IYO
Dear Mr. Callahan:
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 marked 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.
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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
APT 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
Enclosure
3
Page 5 510(k) Notification DICOM IMAGE MANAGER Addition of 3D Visualization Software Module
510(k) Number (if Known): K990248
Device Name: DICOMIT Dicom Image Manager "3D ROI" Option
Indications For Use:
The DICOMIT Dicom Image Manager medical image management system is intended for acceptance, transfer, display, storage and digital processing of medical images. The software component provides functions for performing operations related to image manipulation.
The "3D ROI" software option enables the device to display and manipulate an adjunctive 3D volume image created with data from a diagnostic ultrasound scanning procedure.
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Dmeld W. Slu for DDS
vision Sion Off ivision of Reproductive, Abdominal, EN and Radiological C 510(k) Number