DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)

K992896 · Dental X-Ray Support Systems, Inc. · EGY · Sep 3, 1999 · Radiology

Device Facts

• Record ID: K992896
• Device Name: DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
• Applicant: Dental X-Ray Support Systems, Inc.
• Product Code: EGY · Radiology
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1900
• Device Class: Class 2

Intended Use

The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.

Device Story

The DXSS Automatic X-ray Film Processor is a dental radiographic film processor. Unlike traditional processors that use rollers and gears to transport film through open tanks, this device holds film stationary in a single processing tank. Solutions are stored in four sealed reservoirs; air pressure and vacuum forces move solutions to the film via a valve system. This design eliminates moving parts in contact with the film and reduces odors. A computer board automatically controls and adjusts developer temperature and processing time. The device is intended for use in clinical settings to automate film processing, reducing the need for manual cleaning, draining, and external plumbing. The healthcare provider uses the processed film for diagnostic purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automatic radiographic film processor; stationary film processing chamber; four sealed chemical reservoirs; air pressure/vacuum solution delivery system; computer-controlled developer temperature and timing; electronic draining system; no external plumbing required.

Indications for Use

Indicated for the automatic development, fixation, washing, and drying of radiographic film exposed for medical 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

• Gendex Processor (K945682)

Submission Summary (Full Text)

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K992896

SEP 3 1999

## Section E – 510(k) Summary

| Submitted by: | Jim Jacobson<br>Dental X-ray Support Systems<br>2124 196th Street SW, Suite B<br>Lynnwood, WA 98036<br><br>Phone: [phone]<br>Fax: [phone] |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Submitted: | 08/06/99 |
| Trade Name: | <i>DXSS</i> Automatic X-ray Film Processor |
| Common Name: | Film Processor |
| Classification Name: | Dental Automatic Radiographic Film Processor<br>(Per 21 CFR section 892.1900) |
| Substantial Equivalence: | Gendex Processor K945682 02/09/95 |
| Description of Device: | Dental automatic radiographic film processor |
| Intended Use: | The <i>DXSS</i> Automatic X-ray Film Processor is an<br>automatic radiographic film processor, a diagnostic<br>device intended to be used to develop, fix, wash, and dry<br>automatically and continuously film exposed for medical<br>purposes. This is the sole purpose of this device. |
| Comparison Summary: | Unlike predicate devices which use rollers and gears to<br>pull film through a series of open solution tanks, our<br>processor holds film stationary in one processing tank.<br>Furthermore, solutions are contained in 4 sealed<br>reservoirs. Air pressure and vacuum forces the solutions<br>up to the film, through a valve system. Film is never<br>touched by a moving part, which is unlike other<br>processors on the market. Developer temperature and time<br>is controlled and adjusted automatically by a computer<br>board. Maintenance is relatively low due to electronic<br>draining; other processors require frequent manual<br>cleaning and draining. Chemistry life is prolonged due to<br>the sealed reservoirs, which also prevent the odors<br>associated with open solution tanks. No plumbing is<br>required as it is in most predicate devices. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 3 1999

Mr. Jim Jacobson Owner Dental X-rav Support Systems 2124-19610 Street SW Suite B Lynnwood, WA 98036

Dear Mr. Jacobson:

Re:

K992896 DXSS Automatic X-ray Film Processor Dated: August 24, 1999 Received: August 27, 1999 Requlatory Class: II (two) Product Code: 90 EGY 21 CFR 892,1900

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 (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 requlatory 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/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): K992896

Device Name:

Indications For Use:

Device Name: DXSS Automatic X-ray Film Processor

Applicant: Dental X-ray Support Systems, Jim Jacobson

The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qimil. A. Seymon

on Sign-Off) vision of Reproductive, Abdominal, E and Radiological D

510(k) Number

Prescription Use √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)