Dilon 6800 Acella (Acella)

FDA 510(k) K110384 · Dilon Technologies, Inc.

Substantially Equivalent

510(k) numberK110384

Submission

Device name
Dilon 6800 Acella (Acella)
Applicant
Dilon Technologies, Inc.
Stillwater, MN, US
Received
February 10, 2011
Decision date
May 3, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYX – Camera, Scintillation (Gamma)
Device class
Class I (low risk)
Regulation
21 CFR 892.1100
Specialty
Radiology

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Questions and answers

When was Dilon 6800 Acella (Acella) cleared by the FDA?

Dilon 6800 Acella (Acella) (K110384) received a 510(k) decision of Substantially Equivalent on May 3, 2011, 82 days after the submission was received.

What is the product code of K110384?

The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.