FDA 510(k)

AnyScan 3.0 NM Scanner Family

K-Number: K253844 · 2025-12-30

ApplicantMediso Medical Imaging Systems, Ltd.

Decision Date2025-12-30

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AnyScan 3.0 NM Scanner Family is the device name listed in this FDA 510(k) record. The listed applicant is Mediso Medical Imaging Systems, Ltd.. It received FDA 510(k) clearance on 2025-12-30 under 510(k) number K253844. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AnyScan 3.0 NM Scanner Family?

AnyScan 3.0 NM Scanner Family is a medical device that received FDA 510(k) clearance on 2025-12-30. The listed applicant is Mediso Medical Imaging Systems, Ltd.. The 510(k) number is K253844.

When did AnyScan 3.0 NM Scanner Family receive FDA 510(k) clearance?

AnyScan 3.0 NM Scanner Family received FDA 510(k) clearance on 2025-12-30, under 510(k) number K253844.

Who is the listed applicant for AnyScan 3.0 NM Scanner Family?

The FDA 510(k) record lists Mediso Medical Imaging Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AnyScan 3.0 NM Scanner Family?

The FDA product code for AnyScan 3.0 NM Scanner Family is KPS.

Related Devices (Code: KPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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