UMI X-RAY FILM CASSETTE

K971431 · Umi Intl. · IXA · May 20, 1997 · Radiology

Device Facts

• Record ID: K971431
• Device Name: UMI X-RAY FILM CASSETTE
• Applicant: Umi Intl.
• Product Code: IXA · Radiology
• Decision Date: May 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1850
• Device Class: Class 2

Intended Use

X-Ray Film's Change for X-Ray Machine

Device Story

Device is an X-ray film cassette used in radiographic imaging. It functions as a light-tight container to hold X-ray film during exposure to X-ray radiation. Used in clinical radiology settings by radiologic technologists or physicians. The cassette protects the film from light exposure while allowing X-rays to pass through to record the image. It serves as a standard accessory for conventional radiographic equipment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiographic film cassette; light-tight enclosure for X-ray film; passive mechanical device; no electronic or software components.

Indications for Use

Indicated for use as a component in X-ray machines for holding X-ray film during radiographic imaging procedures.

Regulatory Classification

Identification

A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 20 1997

Kwang Chae Jung Owner/President UMI International 18 Roberts Drive Bedford, MA 07130 Re: K971431

X-Ray Film Cassette/Radiographic Dated: April 15, 1997 Received: April 17, 1997 .. Regulatory class: II 21 CFR 892.1850/Procode: 90 IXA

Dear Mr. Jung:

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 exclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 anual registration, listing of devices, good manufacturing practice, labeling, and probabitions 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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,

William 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

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## Π°ΠυΜΙ International

18 Roberts Drive Bedford, MA 01730 U.S.A. Tel. [phone] Fax [phone]

## Indications for Use Statement

## 510(k) Number( if known )

Device : X-Ray Film Cassette/Radiographic

Indications for Use :

X-Ray Film's Change for X-Ray Machine

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

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Concurrence of CDRH, Office of Device Evaluation(ODE)

Simil A. Seppon

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use ( Per 21 CFR 801.109 ) OR

Over-The-Counter Use

(Optional Format 1-2-96)