Rsa-Cms

FDA 510(k) K042383 · Medis Medical Imaging Systems BV

Substantially Equivalent

510(k) numberK042383

Submission

Device name
Rsa-Cms
Applicant
Medis Medical Imaging Systems BV
Leiden, NL
Received
September 1, 2004
Decision date
October 20, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Rsa-Cms cleared by the FDA?

Rsa-Cms (K042383) received a 510(k) decision of Substantially Equivalent on October 20, 2004, 49 days after the submission was received.

What is the product code of K042383?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.