PRACTICE PARTNER

K926315 · Rs Imaging · LMD · Dec 13, 1993 · Radiology

Device Facts

Record IDK926315
Device NamePRACTICE PARTNER
ApplicantRs Imaging
Product CodeLMD · Radiology
Decision DateDec 13, 1993
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.2020
Device ClassClass 1

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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