FDA 510(k)

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

N.º K: K253459 · 2026-04-24

Fecha de decisión2026-04-24

Código de productoNQQ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K253459. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)?

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K253459.

When did OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) receive FDA 510(k) clearance?

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) received FDA 510(k) clearance on 2026-04-24, under 510(k) number K253459.

Who is the listed applicant for OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)?

The FDA product code for OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) is NQQ.

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Fuente oficial

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