RTLX

FDA 510(k) K992392 · Infimed, Inc.

Substantially Equivalent

510(k) numberK992392

Submission

Device name
RTLX
Applicant
Infimed, Inc.
Liverpool, NY, US
Received
July 19, 1999
Decision date
March 31, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUH – System, X-Ray, Extraoral Source, Digital
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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K093066I5 Digital X-Ray Imaging System, Model I5OWB · Traditional 03/16/2010SE
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K992794Stingray DR, Model 1MQB · Traditional 11/09/1999SE
K992575Cardiovascular Workstation, Model CWS 5000/CWS 3000LLZ · Traditional 10/07/1999SE
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K963037PatriotLLZ · Traditional 09/27/1996SE

Questions and answers

When was RTLX cleared by the FDA?

RTLX (K992392) received a 510(k) decision of Substantially Equivalent on March 31, 2000, 256 days after the submission was received.

What is the product code of K992392?

The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.