(14 days)
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Not Found
No
The summary describes standard image processing and visualization software without mentioning AI or ML capabilities.
No.
The device is described as a software application for display, 3D visualization, and processing of medical images, and for simulation/evaluation in dental procedures. It is intended to assist in diagnosis and planning, not to treat, cure, mitigate, or prevent disease.
Yes
The intended use explicitly states "assist in diagnosis," which indicates its role in the diagnostic process.
Yes
The device is described as a "software application" and its functions are entirely software-based (display, visualization, processing, rendering, review, storage, printing, distribution of images, simulation, evaluation, planning). It explicitly states it utilizes "standard PC hardware," implying the device itself is the software component running on existing hardware, not a new hardware 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.
- ILUMA VISION's Function: ILUMA VISION is a software application that processes and visualizes medical images (CT, MRI, 3D Ultrasound). It works with images generated by scanning devices, not with biological samples.
- Intended Use: The intended use describes the software's role in displaying, processing, and assisting in the diagnosis based on these images. This is distinct from analyzing biological samples.
Therefore, ILUMA VISION falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
ILUMA VISION is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologist, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute DICOM 3.0 compliant images, utilizing standard PC hardware. Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. The device is not intended for use with mammography.
Product codes
LLZ
Device Description
ILUMA VISION is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologist, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute DICOM 3.0 compliant images, utilizing standard PC hardware. Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MRI, 3D Ultrasound
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist, clinicians, referring physicians and other qualified individuals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2008
IMTEC Corporation % Mr. Jay Y. Kogoma Sr. Staff Engineer -- Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K081347
Trade/Device Name: ILUMA Vision v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: May 12, 2008 Received: May 14, 2008
Dear Mr. Kogoma:
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 either 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.
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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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
---|---|---|
21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
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Image /page/2/Picture/0 description: The image shows the logo for IMTEC Corporation. The logo consists of a stylized triangular shape on the left, followed by the word "IMTEC" in bold, sans-serif font. Below "IMTEC" is the word "CORPORATION" in a smaller, sans-serif font. A registered trademark symbol is located to the right of the word "IMTEC".
Indications for Use
510(k) Number (if known): 长۵8 l347 ILUMA Vision v2.0 Device Name: Indications for Use:
ILUMA VISION is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologist, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute DICOM 3.0 compliant images, utilizing standard PC hardware. Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. The device is not intended for use with mammography.
AND/OR X Prescription Use (Part 21 CFR 801 Subpart D)
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)
Amuth Whay
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
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