Nuclear Medicine Laser Imager

Q: What is the product code of K923536?

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) K923536 · General Scanning, Inc.

Substantially Equivalent

510(k) numberK923536

Submission

Device name: Nuclear Medicine Laser Imager
Applicant: General Scanning, Inc.
Watertown, MA, US
Received: July 16, 1992
Decision date: November 30, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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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More from Mitsubishi Electric Corporation Kyoto Works

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Questions and answers

When was Nuclear Medicine Laser Imager cleared by the FDA?

Nuclear Medicine Laser Imager (K923536) received a 510(k) decision of Substantially Equivalent on November 30, 1992, 137 days after the submission was received.

What is the product code of K923536?

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