(41 days)
Not Found
No
The summary describes basic image viewing and quantification software and does not mention AI, ML, or related concepts.
No
The device is described as software designed to view and quantify echographic image data, which falls under diagnostic or image processing functions, not therapeutic treatment.
No
The software is designed to view and quantify echographic image data, but there is no indication that it interprets or analyzes this data to provide a diagnosis. Its function is to present and measure existing image data, which is a step preceding diagnosis, not a diagnostic act in itself.
Yes
The device is explicitly described as a "software application package" designed to view and quantify existing echographic image data. There is no mention of any hardware component being part of the device itself.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use/Indications for Use: The intended use is to "view and quantify echographic image data." This describes a tool for analyzing medical images, not for performing tests on biological samples (like blood, urine, or tissue) to diagnose or monitor a disease.
- Device Description: The description reinforces the intended use as a software package for viewing and quantifying echographic images.
- Input Imaging Modality: The input is "echographic image data," which is medical imaging data, not biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples.
- Providing diagnostic information based on the analysis of biological samples.
- Measuring analytes in biological samples.
- Any connection to laboratory testing.
In summary, the Qontrast software is designed to process and analyze medical images (echographic data), which falls under the category of medical imaging software, not In Vitro Diagnostics. IVDs are specifically designed to perform tests on samples taken from the human body to provide information about a person's health.
N/A
Intended Use / Indications for Use
Qontrast software is a Windows 2000/Windows XP software application package. It is designed to view and quantify echographic image data.
Product codes (comma separated list FDA assigned to the subject device)
LLZ - 892.2050
Device Description
Not Found
Mentions image processing
System, Image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
echographic image data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
MAR 2 9 2004
510(k) Summary Amid. s.r.l. Qontrast
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
| Colleen Densmore, Official Correspondent | |
|---|---|
| The Anson Group | |
| 7992 Castleway Drive | |
| Indianapolis, Indiana 46250 | |
| Phone: | (317) 849-1916 |
| Facsimile: | (317) 577-9070 |
| Contact Person: | Carri Graham |
| Date: | February 16, 2004 |
| 807.92(a)(2) | |
| Trade Name: | Qontrast software |
| Common Name: | Picture archiving and communications system |
| Classification Name(s): | System, Image processing |
| Classification Number: | LLZ - 892.2050 |
| 807.92(a)(3) |
Predicate Device(s)
| ATL d/b/a Philips Ultrasound |
|---|
| QLAB Software |
| K021966 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is facing right and is positioned above the text "DEPARTMENT OF HEALTH & HUMAN." The text is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2004
AMID, s.r.l. % Ms. Carri Graham Consultant The Anson Group, LLC 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K040399 Trade/Device Name: Qontrast Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 13, 2004 Received: February 17, 2004
Dear Ms. Graham:
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 your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
2
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. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040399
Qontrast Software Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Qontrast software is a Windows 2000/Windows XP software application package. It is designed to view and quantify echographic image data.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Broodon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K040399
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