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K Number
K983918
Device Name
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
Manufacturer
MASTEK, INC.
Date Cleared
1999-03-12

(128 days)

Product Code
IXA
Regulation Number
892.1850
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. The R-CLIP positions and secures limbs for radiographic x-ray exposure.
  2. The R-CLIP provides vertical and horizontal limb positioning relative to plane of radiographic view.
  3. The R-CLIP avoids x-ray exposure to surgical staff by eliminating the need to hold the limb during exposure.
  4. The R-CLIP is reusable and autoclavable. The R-CLIP Retainer kit is sterile, single use only.
Device Description

Radiolucent Cassette LIMB Positioner (R-Clip)

AI/ML Overview

This is a 510(k) clearance letter for a device called "Radiolucent Cassette LIMB Positioner (R-Clip)". The letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the provided documents do not contain information about the device's acceptance criteria or any study that proves the device meets those criteria.

The documents are a regulatory clearance letter and a description of the device's intended use. They do not detail the technical performance or testing conducted to support the substantial equivalence claim.

Therefore, I cannot provide the requested information.

§ 892.1850 Radiographic film cassette.

(a)
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.(b)
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.