FDA 510(k)

Atellica® IM TSH3-Ultra II (TSH3ULII)

N.º K: K251543 · 2026-02-06

SolicitanteSiemens Healthcare Diagnostics, Inc.

Fecha de decisión2026-02-06

Código de productoJLW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Atellica® IM TSH3-Ultra II (TSH3ULII) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K251543. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Atellica® IM TSH3-Ultra II (TSH3ULII)?

Atellica® IM TSH3-Ultra II (TSH3ULII) is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K251543.

When did Atellica® IM TSH3-Ultra II (TSH3ULII) receive FDA 510(k) clearance?

Atellica® IM TSH3-Ultra II (TSH3ULII) received FDA 510(k) clearance on 2026-02-06, under 510(k) number K251543.

Who is the listed applicant for Atellica® IM TSH3-Ultra II (TSH3ULII)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atellica® IM TSH3-Ultra II (TSH3ULII)?

The FDA product code for Atellica® IM TSH3-Ultra II (TSH3ULII) is JLW.

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Dispositivos relacionados (Código: JLW)

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Fuente oficial

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