(373 days)
None
Not Found
No
The summary describes a passive accessory for converting X-ray energy to light, with no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
This device converts X-ray energy into light energy, which is a function related to diagnostic imaging, not therapy.
No
Explanation: The device is described as an "accessory to a cassette to convert X-Ray energy into light energy," which indicates it is a component for image acquisition, not for diagnosing medical conditions. It does not process or interpret medical images to provide diagnostic information.
No
The intended use describes the device as an "accessory to a cassette to convert X-Ray energy into light energy," which strongly suggests a hardware component involved in the energy conversion process. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as an "Accessory to a cassette to convert X-Ray energy into light energy." This describes a physical process related to capturing an image, not a diagnostic test performed on biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device appears to be a component used in the process of generating an X-ray image, which is a form of medical imaging, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Accessory to a cassette to convert X-Ray energy into light energy.
Product codes
90 EAM
Device Description
Konica Intensifying Screens MD100 and MM150
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray energy
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1960 Radiographic intensifying screen.
(a)
Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a sans-serif font and is black. The text is on a white background. There are some black lines on the left side of the text.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Russell D. Munves c/o Storch Amini & Munves, P.C. The Chrysler Building 405 Lexington Avenue New York, NY 10174
Re:
K963913 Konica Intensifying Screens MD100 and MM150 Dated: August 15, 1997 Received: August 18, 1997 Regulatory class: I 21 CFR 892.1960/Procode: 90 EAM
OCT - 8 1997
Dear Mr. Munves:
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 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). 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 requirement, 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 not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 question 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" (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/dsmamain.html".
Sincerely yours,
W. Liao Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(l:) Number (if known):
MD100 & MM150 Intensifier Screens
Device Name:_
Indications For Use:
ست. مه س
Accesscry to a cassette to convert X-Ray energy into light energy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K963913 |
|---|---|
| --------------- | --------- |
| Prescription Use_ | OR | Over-The-Counter Use_ |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |