Multispect 2 Dual Detector Camera System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Multispect(Tm) 2 Dual Detector Camera System

510(k) Number

K922373 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Siemens Gammasonics, Inc. →

• What is the Multispect 2 Dual Detector Camera System used for?

  The Multispect 2 Dual Detector Camera System is designed for computed emission tomography in radiology, capturing and processing medical images using dual detector technology to provide detailed diagnostic imaging.

• Is the Multispect 2 Dual Detector Camera System reusable or single-use?

  The Multispect 2 Dual Detector Camera System is supplied as a reusable system, meaning it can be used multiple times for imaging procedures in radiology departments.

• What is the regulatory status of the Multispect 2 Dual Detector Camera System?

  The device is authorized under FDA 510(k) clearance with product code KPS and regulation number 892.1200, classified as a Class II device for computed emission tomography systems.

• Who manufactures the Multispect 2 Dual Detector Camera System?

  The Multispect 2 Dual Detector Camera System is manufactured by Siemens Gammasonics, Inc., a company specializing in medical imaging equipment.