LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D

K022154 · Fischer Industries, Inc. · IXW · Sep 30, 2002 · Radiology

Device Facts

• Record ID: K022154
• Device Name: LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
• Applicant: Fischer Industries, Inc.
• Product Code: IXW · Radiology
• Decision Date: Sep 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1900
• Device Class: Class 2

Intended Use

The Level 356 X-Ray Film Processor is a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes. This is the sole purpose of this device.

Device Story

Level 356 X-Ray Film Processor is an automatic radiographic film processor; processes exposed medical and dental film. Device uses transport rollers to move film through developer, fixer, and wash water tanks. Computer board automatically controls solution temperatures. No plumbing required. Operated by clinical staff in medical or dental settings. Output is processed, dry radiographic film for diagnostic review by healthcare providers. Benefits include automated, continuous film processing workflow.

Clinical Evidence

No clinical data provided; device is a mechanical film processor. Substantial equivalence is based on technological comparison to the predicate device.

Technological Characteristics

Automatic radiographic film processor; transport roller system for film movement; developer, fixer, and wash tanks; computer board for automatic temperature control; no plumbing required; standalone unit.

Indications for Use

Indicated for the automatic development, fixation, washing, and drying of radiographic film exposed for medical and dental diagnostic purposes.

Regulatory Classification

Identification

An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

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.

Predicate Devices

• Futura System 30 DX (K940112)

Submission Summary (Full Text)

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Fischer Industries Inc.®

2630 Kaneville Court, Geneva, IL 60134
[phone] • Fax [phone] www.fischerind.com

## Section B – 510(K) Summary

K022154

| Submitted by: | Fischer Industries, Inc.<br>2630 Kaneville Court<br>Geneva, IL 60134<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Phil O'Keefe |
| Date Submitted: | 6/11/02 |
| Trade Name of this Device: | Level 356 X-Ray Film Processor |
| Common or Useful Name: | Film Processor |
| Classification Name: | Automatic Radiographic Film Processor |
| Substantial Equivalence: | Futura System 30 DX<br>K940112<br>4/11/95 |
| Description of Device: | Automatic Radiographic Film Processor |
| Intended Use: | The Level 356 X-Ray Film Processor is a<br>diagnostic device intended to be used to<br>develop, fix, wash, and dry automatically<br>and continuously film exposed for medical<br>and dental purposes. This is the sole purpose<br>of this device. |
| Comparison Summary: | This film processor is operates like most<br>predicate devices in that it uses a series of<br>transport rollers to pull film through a series<br>of open developer solution, fixer solution,<br>and wash water tanks. Developer and fixer<br>solution temperature is controlled<br>automatically by a computer board. No<br>plumbing is required |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 3 0 2002

Mr. Philip J. O'Keefe Director of Engineering Fischer Industries, Inc. 2630 Kaneville Court GENEVA IL 60134

Re: K022154

Trade/Device Name: Level 356 X-Ray Film Processor Models MD and MD-D Regulation Number: 21 CFR \$892.1900 Regulation Name: Automatic radiographic film processor Regulatory Class: II Product Code: 90 IXW Dated: June 27, 2002 Received: July 2, 2002

Dear Mr. O'Keefe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C Crozdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (il known): K022154

Ocvice Name:Level 356 X-Ray Film Processor, Models MD & MD-D

Indications For Use: The Level 356 X-Ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to develope, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes. This is the sole purpose of this device.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER P/ NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022154

Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Formal