MD100 & MM150

K963913 · Konica Medical Corp. · EAM · Oct 8, 1997 · Radiology

Device Facts

• Record ID: K963913
• Device Name: MD100 & MM150
• Applicant: Konica Medical Corp.
• Product Code: EAM · Radiology
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1960
• Device Class: Class 1

Intended Use

Accessory to a cassette to convert X-Ray energy into light energy.

Device Story

Konica Intensifying Screens MD100 and MM150 function as accessories to X-ray cassettes; primary purpose is conversion of X-ray energy into light energy to facilitate radiographic image capture. Used in clinical radiology settings by trained technicians or radiologists. Device interacts with X-ray film within a cassette; output is visible light exposure to the film, enabling diagnostic image formation. Benefits include improved image quality and reduced patient radiation exposure compared to non-intensified imaging.

Clinical Evidence

Bench testing only.

Technological Characteristics

Intensifying screen for X-ray cassettes; converts X-ray energy to light energy. Passive radiological accessory; no electronic components, software, or energy source.

Indications for Use

Indicated for use as an accessory to an X-ray cassette to convert X-ray energy into light energy for radiographic imaging.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

OCT - 8 1997

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: 1
21 CFR 892.1960/Procode: 90 EAM

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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

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Page 1 of 1

510(k) Number (if known): K963913

MD100 & MM150 Intensifier Screens

Device Name:

Indications For Use:

Accessory 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)

David G. Byrnes
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963913

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Prescription Use ☑
(Per 21 CFR 801.109)