AMADEO M-DR mini, AMADEO M-AX mini

Q: What is the product code of K182317?

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

FDA 510(k) K182317 · Oehm Und Rehbein GmbH

Substantially Equivalent

510(k) numberK182317

Submission

Device name: AMADEO M-DR mini, AMADEO M-AX mini
Applicant: Oehm Und Rehbein GmbH
Rostock, DE
Received: August 27, 2018
Decision date: September 24, 2018
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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More from H&abyz Co., Ltd.

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Questions and answers

When was AMADEO M-DR mini, AMADEO M-AX mini cleared by the FDA?

AMADEO M-DR mini, AMADEO M-AX mini (K182317) received a 510(k) decision of Substantially Equivalent on September 24, 2018, 28 days after the submission was received.

What is the product code of K182317?

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