Polaroid Radiographic Film Processor

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K812088 ↗

FDA Product Code

IXW

Device Class

Class II

Regulation

21 CFR Part 892.1900

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Polaroid Tpx Radiographic Film

  Class I

  FDA 510(k) K811352 Active Cleared 18 Jun 1981

• Polaroid Land Camera for Endoscopy

  Class I

  FDA 510(k) K792512 Active Cleared 20 Dec 1979

• Polaroid Radiographic Film Cassette

  Not classified

  FDA 510(k) K812089 Active Cleared 31 Aug 1981

• Polaroid Instant Endocamera

  Class I

  FDA 510(k) K812542 Active Cleared 19 Oct 1981

• What is the Polaroid Radiographic Film Processor used for?

  The Polaroid Radiographic Film Processor is an automatic device specifically designed for processing radiographic film in radiology departments. It streamlines the development process to produce clear diagnostic images efficiently.

• Is the Polaroid Radiographic Film Processor a single-use or reusable device?

  The Polaroid Radiographic Film Processor is a reusable device designed for continuous operation in radiology departments. It is an automatic processor that can handle multiple film processing cycles without requiring replacement after each use.

• What are the regulatory approvals for the Polaroid Radiographic Film Processor?

  The Polaroid Radiographic Film Processor is classified as a Class II medical device and was cleared under FDA 510(k) K812088 in 1981. It is regulated under product code IXW and intended specifically for use in radiology departments.

• What are the key specifications of the Polaroid Radiographic Film Processor?

  The Polaroid Radiographic Film Processor is an automatic device with product code IXW. It was manufactured by Polaroid Corp. and received FDA clearance as substantially equivalent to predicate devices in the radiology field.