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FDA 510(k)

AnyScan 3.0 NM Scanner Family

K-Number: K253844 · 2025-12-30

Decision Date2025-12-30
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AnyScan 3.0 NM Scanner Family is a medical device manufactured by Mediso Medical Imaging Systems, Ltd.. It received FDA 510(k) clearance on 2025-12-30 under approval 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. It is manufactured by Mediso Medical Imaging Systems, Ltd.. The 510(k) number is K253844.

When was AnyScan 3.0 NM Scanner Family approved by the FDA?

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

What company makes AnyScan 3.0 NM Scanner Family?

AnyScan 3.0 NM Scanner Family is manufactured by Mediso Medical Imaging Systems, Ltd..

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)

Official Source

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