Porta 100HF

FDA 510(k) K122697 · Job Corporation

Substantially Equivalent

510(k) numberK122697

Submission

Device name
Porta 100HF
Applicant
Job Corporation
Gardena, CA, US
Received
September 4, 2012
Decision date
October 5, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZL – System, X-Ray, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1720
Specialty
Radiology

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Questions and answers

When was Porta 100HF cleared by the FDA?

Porta 100HF (K122697) received a 510(k) decision of Substantially Equivalent on October 5, 2012, 31 days after the submission was received.

What is the product code of K122697?

The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.