Afga Video Imager, Various Models

Q: What is the product code of K903238?

The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.

FDA 510(k) K903238 · Enhanced Imaging Technologies, Inc.

Substantially Equivalent

510(k) numberK903238

Submission

Device name: Afga Video Imager, Various Models
Applicant: Enhanced Imaging Technologies, Inc.
Orangeburg, NY, US
Received: July 18, 1990
Decision date: November 2, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LMC – Camera, Multi Format, Radiological
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.2040
Specialty: Radiology

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K061302	Digital Printer P6000D Series, Model P6000DULMC · Traditional	Mitsubishi Electric Corporation Kyoto Works	06/23/2006SE

More from Mitsubishi Electric Corporation Kyoto Works

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Questions and answers

When was Afga Video Imager, Various Models cleared by the FDA?

Afga Video Imager, Various Models (K903238) received a 510(k) decision of Substantially Equivalent on November 2, 1990, 107 days after the submission was received.

What is the product code of K903238?

The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.