!M1

FDA 510(k) K170607 · Solutions For Tomorrow AB

Substantially Equivalent

510(k) numberK170607

Submission

Device name
!M1
Applicant
Solutions For Tomorrow AB
Vackelsang, SE
Received
March 1, 2017
Decision date
July 17, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZL – System, X-Ray, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1720
Specialty
Radiology

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K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)IZL · Traditional Poskom Co., Ltd.02/23/2026SE
K250976Airbile-100IZL · Traditional Poskom Co., Ltd.12/19/2025SE
K251710Mobile X-ray unit (!M1)IZL · Traditional Solutions For Tomorrow AB10/24/2025SE
K243864BONX805IZL · Traditional Bontech Co., Ltd.09/12/2025SE
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K251223HnX-P1, HnX-PBIZL · Traditional H&abyz Co., Ltd.08/04/2025SE

More from H&abyz Co., Ltd.

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K251710Mobile X-ray unit (!M1)IZL · Traditional 10/24/2025SE
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Questions and answers

When was !M1 cleared by the FDA?

!M1 (K170607) received a 510(k) decision of Substantially Equivalent on July 17, 2017, 138 days after the submission was received.

What is the product code of K170607?

The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.