Medi View

FDA 510(k) K812152 · Medical Synergy

Substantially Equivalent

510(k) numberK812152

Submission

Device name
Medi View
Applicant
Medical Synergy
Mchenry, IL, US
Received
July 29, 1981
Decision date
September 9, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IXC – Illuminator, Radiographic-Film
Device class
Class I (low risk)
Regulation
21 CFR 892.1890
Specialty
Radiology

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K954199VoxboxIXC · Traditional Voxel09/29/1995SE
K952188Adviewer 2000IXC · Traditional Adp , Ltd.05/30/1995SE
K922848Ultralite X-Ray Film IlluminatorIXC · Traditional A & S Trading Co.09/28/1992SE
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K883702Excelview IlluminatorIXC · Traditional Excel Medical Products, Inc.09/19/1988SE

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Questions and answers

When was Medi View cleared by the FDA?

Medi View (K812152) received a 510(k) decision of Substantially Equivalent on September 9, 1981, 42 days after the submission was received.

What is the product code of K812152?

The FDA product code is IXC – Illuminator, Radiographic-Film, a Class I (low risk) device regulated under 21 CFR 892.1890.