IDX-60 Intraoral X-Ray

FDA 510(k) K993958 · X-Cel X-Ray Corp.

Substantially Equivalent

510(k) numberK993958

Submission

Device name
IDX-60 Intraoral X-Ray
Applicant
X-Cel X-Ray Corp.
Crystal Lake, IL, US
Received
November 22, 1999
Decision date
February 14, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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More from Dental Imaging Technologies Corporation

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K811230X-Cell X-Ray #'S P-75W/P-75MKPR · Traditional 06/23/1981SE

Questions and answers

When was IDX-60 Intraoral X-Ray cleared by the FDA?

IDX-60 Intraoral X-Ray (K993958) received a 510(k) decision of Substantially Equivalent on February 14, 2000, 84 days after the submission was received.

What is the product code of K993958?

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