Sunipan Imaging System & Accessories

FDA 510(k) K060149 · Suni Medical Imaging, Inc.

Substantially Equivalent

510(k) numberK060149

Submission

Device name
Sunipan Imaging System & Accessories
Applicant
Suni Medical Imaging, Inc.
San Jose, CA, US
Received
January 20, 2006
Decision date
February 3, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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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Questions and answers

When was Sunipan Imaging System & Accessories cleared by the FDA?

Sunipan Imaging System & Accessories (K060149) received a 510(k) decision of Substantially Equivalent on February 3, 2006, 14 days after the submission was received.

What is the product code of K060149?

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