Sentinella 102

FDA 510(k) K110601 · General Equipment For Medical Imaging, S.A.

Substantially Equivalent

510(k) numberK110601

Submission

Device name
Sentinella 102
Applicant
General Equipment For Medical Imaging, S.A.
Valencia, ES
Received
March 2, 2011
Decision date
March 18, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA
Third-party review
Yes

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 Sentinella 102 cleared by the FDA?

Sentinella 102 (K110601) received a 510(k) decision of Substantially Equivalent on March 18, 2011, 16 days after the submission was received.

What is the product code of K110601?

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