KONICA DIRECT DIGITIZER, MODEL DD-341 by KONICA CORP.

The Konica Direct Digitizer (Computed Radiography Device) Model DD-341/Regius 150 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.

Device Description

Konica Direct Digitizer, Model DD-341/Regius 150 is a Computed Radiography Device.

AI/ML Overview

This document is a 510(k) clearance letter for the Konica Direct Digitizer, Model DD-341/Regius 150. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter acknowledges the company's intent to market the device and states that the FDA has determined it is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies from the provided text.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 1999

Russell D. Munves Storch Amini & Munves 405 Lexington Avenue New York, New York 10174 Re: K990359

Konica Direct Digitizer, Model DD-341/Regius 150 Dated: February 4, 1999 Received: February 5, 1999 Regulatory Class: II 21 CFR 892.1630/Procode: 90 MQB

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 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). 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 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 requirements, 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 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 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"(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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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510(k) Number (If known): K990359

Device Name: Konica Direct Digitizer, Model DD-341/Regius 150

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Thail A. Seppanen

(Division Sign-Off) (Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number_

Prescription Use

. ____________________________________________________________________________________________________________________________________________________________________________

OR Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.