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FDA 510(k)

The AIO Solution 3.0

K-Number: K202068 · 2020-08-14

ApplicantOrfit Industries NV
Decision Date2020-08-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

The AIO Solution 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries NV. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K202068. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The AIO Solution 3.0?

The AIO Solution 3.0 is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is Orfit Industries NV. The 510(k) number is K202068.

When did The AIO Solution 3.0 receive FDA 510(k) clearance?

The AIO Solution 3.0 received FDA 510(k) clearance on 2020-08-14, under 510(k) number K202068.

Who is the listed applicant for The AIO Solution 3.0?

The FDA 510(k) record lists Orfit Industries NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The AIO Solution 3.0?

The FDA product code for The AIO Solution 3.0 is IYE.

Other records listing Orfit Industries NV as applicant

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.

K200282Orfit Aerial CouchtopK191158The AIO SolutionK171734HP PRO Positioning DeviceK162355Raycast MammoRx Carbon Fibre Breast BoardK162862Raycast High Precision Lung Board Solution

Related Devices (Code: IYE)

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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