Class Class II

!M1 (K241980)

K241980 2025-05-06 Traditional
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Description

!M1 by Solutions For Tomorrow AB, an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241980
Clearance Date2025-05-06
Clearance TypeTraditional
Product CodeIZL
Regulation Number892.1720

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Predicate lineage for K241980

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. !M1 (K241980) cites 11 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K230175Digital Radiography CXDI-CS01Canon, Inc.2023
K223267SKR 3000Konica Minolta, Inc.2022
K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.2022
K200418VIVIX-S VWVieworks Co., Ltd.2020
K170607!M1Solutions For Tomorrow AB2017
K162504SKR 3000Konica Minolta, Inc.2016
K141271AERODR SYSTEM 2Konica Minolta, Inc.2014
K133693DIGITAL RADIOGRAPHY CXDI-401C WIRELESSCanon, Inc.2014
K130936AERODR SYSTEM WITH P-31Konica Minolta Medical & Graphic, Inc.2013
K131106DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY...Canon, Inc.2013
K113248AERODR SYSTEM WITH P-21Konica Minolta Medical & Graphic, Inc.2012

Trace the full predicate network for K241980

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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