Mobil-Aid Automatic Exposure Control

FDA 510(k) K813128 · Advanced Instrument Development, Inc.

Substantially Equivalent

510(k) numberK813128

Submission

Device name
Mobil-Aid Automatic Exposure Control
Applicant
Advanced Instrument Development, Inc.
Walker, MI, US
Received
November 5, 1981
Decision date
December 3, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Mobil-Aid Automatic Exposure Control cleared by the FDA?

Mobil-Aid Automatic Exposure Control (K813128) received a 510(k) decision of Substantially Equivalent on December 3, 1981, 28 days after the submission was received.

What is the product code of K813128?

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