TDK MEDICAL GRADE CD-R

K971848 · Tdk Electronics Corporation of America · LMB · Aug 15, 1997 · Radiology

Device Facts

• Record ID: K971848
• Device Name: TDK MEDICAL GRADE CD-R
• Applicant: Tdk Electronics Corporation of America
• Product Code: LMB · Radiology
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2010
• Device Class: Class 1

Intended Use

The TDK Medical Grade CD-R is a storage medium used for picture archiving and exchange of recordable information. The TDK Medical Grade CD-R is a multisession disc with 650MB capacity, which is used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving. The TDK Medical Grade CD-R conforms to ISO 9002, Orange Book, Part II. TDK Medical Grade CD-R should be used only by persons thoroughly trained in the use of the specific picture archiving and communication system being used, with special attention to training in the use of the write/read hardware.

Device Story

TDK Medical Grade CD-R is a 650MB multisession optical storage disc; functions as a medium for acquisition, exchange, display, review, and archiving of medical images within picture archiving and communication systems (PACS). Used in clinical settings by trained personnel operating compatible cardio or mini review stations. Device serves as a physical storage component for digital records; does not perform active processing or analysis. Benefits include reliable long-term storage and portability of medical image data.

Clinical Evidence

No clinical data; bench testing only. Device performance is based on conformance to ISO 9002 and Orange Book Part II standards for optical storage media.

Technological Characteristics

650MB capacity multisession CD-R; conforms to ISO 9002 and Orange Book Part II standards. Passive storage medium; no energy source or active sensing components.

Indications for Use

Indicated for use as a storage medium for picture archiving and exchange of recordable information in conjunction with compatible cardio and mini review stations. Intended for use by trained personnel familiar with specific picture archiving and communication systems and write/read hardware.

Regulatory Classification

Identification

A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF" are written vertically along the left side of the logo.

utar newith Servace

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 1997

Kovo Yokoi Executive Vice President TDK Electronics Corporation of America 12 Harbor Park Drive Port Washington, NY 11050

Re: K971848

TDK Medical Grade CD-R PACS Accessory Dated: May 19, 1997 Received: May 19, 1997 Unclassified Product Code: 90 LMB

Dear Mr. Yokoi:

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 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

through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your of vice 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 question 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.

h. 7liau Yu

Lilian 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

Image /page/0/Picture/17 description: The image shows the word "Enclosure" in a simple, sans-serif font. Above the word, there is a curved line that resembles a partial circle or an arc. The text and the arc are the only elements in the image, set against a plain white background.

{1}------------------------------------------------

K11848

Page I of I

## 510(k) Number (if known):

Device Name: TDK Medical Grade CD-R

Classification Panel:

Indications for Use:

The TDK Medical Grade CD-R is a storage medium used for picture archiving and exchange of recordable information. The TDK Medical Grade CD-R is a multisession disc with 650MB capacity, which is used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving.

The TDK Medical Grade CD-R conforms to ISO 9002, Orange Book, Part II.

TDK Medical Grade CD-R should be used only by persons thoroughly trained in the use of the specific picture archiving and communication system being used, with special attention to training in the use of the write/read hardware.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Bryson

(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devi

**510(k) Number** K77

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use