Search Results
Found 1 results
510(k) Data Aggregation
K Number
K190949Device Name
ScanX Barrier Envelopes
Manufacturer
Air Techniques Inc.
Date Cleared
2019-07-26
(106 days)
Product Code
PEM
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
Air Techniques Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Barrier Envelopes are intended to be used as a disposable barrier for Air Techniques Phosphor Storage Plates. This device is non-sterile and intended for single patient use only.
Device Description
The ScanX barrier envelopes are made from one layer of clear blown polyethylene film and one layer of black blown polyethylene film heat sealed along three edges. An adhesive strip along the fourth edge is used for temporary barrier. Barrier Envelopes are used with Air Techniques' intraoral Phosphor Storage Plates. Barrier Envelopes are non-sterile, and disposable, single use only- discarded after each use.
Ask a Question
Page 1 of 1