AII-PRO 100 PLUS AND ALL-PRO 200

K991435 · All-Pro Imaging Corp. · IXW · May 20, 1999 · Radiology

Device Facts

• Record ID: K991435
• Device Name: AII-PRO 100 PLUS AND ALL-PRO 200
• Applicant: All-Pro Imaging Corp.
• Product Code: IXW · Radiology
• Decision Date: May 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1900
• Device Class: Class 2

Intended Use

The All-Pro 100 Plus and All-Pro 200 are automatic x-ray film processors. They develop, fix, wash and dry medical x-ray film. Properly processed x-ray films are available for reading by medical practitioners more rapidly and with more consistency than with manual processing.

Device Story

All-Pro 100 Plus and All-Pro 200 are automatic x-ray film processors; designed to automate development, fixation, washing, and drying of medical x-ray film. Devices accept exposed x-ray film as input; perform chemical processing and mechanical drying; output processed film ready for clinical review. Used in clinical settings by radiology staff or technicians. Automated processing provides faster, more consistent film development compared to manual methods, facilitating timely diagnostic interpretation by medical practitioners.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automatic x-ray film processor; mechanical transport system for film; chemical processing tanks for developer and fixer; drying system; electrical power source; standalone unit.

Indications for Use

Indicated for use by medical practitioners to automatically develop, fix, wash, and dry medical x-ray film for diagnostic imaging 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1599

Frederick R. Fisher Vice President All Pro Imaging Corporation 70 Cantiague Rock Road P.O. Box 870 Hicksvile, New York 11801

RE:

K991435 All-Pro Plus & All Pro 200 Dated: April 23, 1999 Received: April 26, 1999 Regulatory Class: II 21 CFR 892.1900/Procode: 90 IXW

Dear Mr. Fisher:

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 redassified 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 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 Requilations, 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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Image /page/1/Picture/0 description: The image shows a logo with the text "All-Pro" in a stylized font. The text is white and bold, set against a background of black vertical stripes. The stripes vary in width and spacing, creating a barcode-like effect. The overall design is simple and high-contrast, making the text stand out.

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510(k) Number: K_99/435

All-Pro 100 Plus and All-Pro 200 Device Name:

## Indications for Use:

The All-Pro 100 Plus and All-Pro 200 are automatic x-ray film processors. They develop, fix, wash and dry medical x-ray film. Properly processed x-ray films are available for reading by medical practitioners more rapidly and with more consistency than with manual processing.

Daniel A. Segerson

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

**Prescription Use**
(Per 21 CFR 801.109)