Monochrome LCD Monitor, RadiForce Model GS310

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

510(k) Number

K060845 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• 4MP Color LCD Monitor, RADIFORCERX430

  Class II

  FDA 510(k) K112466 Active Cleared 27 Oct 2011

• 3.7 Mp Color LCD Monitor, Radiforce MX270W

  Class II

  FDA 510(k) K113240 Active Cleared 20 Apr 2012

• Monochrome LCD Monitor, Radiforce G51

  Class II

  FDA 510(k) K042755 Active Cleared 10 Feb 2005

• 20.1 Monochrome LCD Monitor, Radiforce G21

  Class II

  FDA 510(k) K024358 Active Cleared 25 Mar 2003

• Color LCD Monitor, Flexscan MX300W

  Class II

  FDA 510(k) K073340 Active Cleared 19 Dec 2007

• 2MP Monochrome LCD Monitor, Radiforce GX240

  Class II

  FDA 510(k) K120407 Active Cleared 19 Apr 2012

See all devices from Eizo Nanao Corporation →

• What is the Radiforce GS310 monitor designed for?

  The Radiforce GS310 is a medical imaging display device specifically designed for radiological applications. It is classified as a System, Image Processing, Radiological under the LLZ classification.

• Is the Radiforce GS310 monitor single-use or reusable?

  The Radiforce GS310 is supplied as a single-use monitor and must comply with IEC60601-1-1 requirements. This means it is intended for one-time use in medical imaging environments.

• What regulatory approvals does the Radiforce GS310 have?

  The Radiforce GS310 is subject to FDA 510(k) clearance with decision code SESE, indicating it is substantially equivalent to other legally marketed devices. It was reviewed by the Radiology advisory committee.

• Who is the manufacturer of the Radiforce GS310 monitor?

  The Radiforce GS310 monitor is manufactured by Eizo Nanao Corporation, located in Hakusan, Ishikawa-Ken, Japan. The contact person for this device is HIROAKI HASHIMOTO.