(31 days)
K07106
K07106
No
The summary describes image processing and display capabilities but does not mention AI, ML, or related terms, nor does it provide details about training or test data sets typically associated with AI/ML devices.
No
The device is used for acquisition, processing, review, and archiving of diagnostic images, indicating a diagnostic rather than therapeutic purpose.
Yes.
The device is indicated for processing, review, and archiving of scintigraphy camera output data and related diagnostic images, and mentions displaying kinetic attributes of imaged organs, all of which are steps involved in diagnosis.
Unknown
The provided text describes the function of the device (processing and displaying scintigraphy data) but does not explicitly state whether the device is solely software or includes hardware components. The "Device Description" section is missing, which would typically clarify this.
Based on the provided information, the Mirage system 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. They are used to provide information for diagnosis, monitoring, or screening.
- Mirage System Function: The description states the Mirage system is for the "acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images." Scintigraphy is an imaging technique that involves injecting a radioactive tracer into the body and then using a camera to detect the radiation emitted by the tracer. This is an in vivo (within the living body) imaging process, not an in vitro (outside the living body) diagnostic test.
- Focus on Images: The description emphasizes the processing and display of "diagnostic images" and "pseudo three-dimensional renderings," which are characteristic of medical imaging systems, not IVDs.
Therefore, the Mirage system falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.
Product codes
LLZ
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scintigraphy camera output data
Anatomical Site
imaged organs
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)
K07106
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center appears to be a stylized eagle or bird-like figure composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 2 2007
Philippe Briandet, Ph.D. President Segami Corporation 8325 Guilford Road, Suite B COLUMBIA MD 21046
Re: K070683
Trade/Device Name: Mirage Cedars Option Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 9, 2007 Received: March 13, 2007
Dear Dr. Briandet:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "FDA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are located at the bottom of the logo.
Protesting and Promoting Public Health
1
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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/cdrl/industry/support/index.litml.
Sincerely yours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SPECIAL 510(k) Mirage Cedars Option
070683 510(k) Number (if known):_
Device Name: Mirage Cedars Option .
Indications for Use:
The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.
(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)
(Division Sign-Off) Division of Reproxime :: sodominal, and Radiological Device
§10(k) Number K07106
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Appendix II-2