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FDA 510(k)

Delta4 Insight

K-Number: K223234 · 2024-01-16

ApplicantScandidos AB
Decision Date2024-01-16
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Delta4 Insight is the device name listed in this FDA 510(k) record. The listed applicant is Scandidos AB. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K223234. 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 Delta4 Insight?

Delta4 Insight is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Scandidos AB. The 510(k) number is K223234.

When did Delta4 Insight receive FDA 510(k) clearance?

Delta4 Insight received FDA 510(k) clearance on 2024-01-16, under 510(k) number K223234.

Who is the listed applicant for Delta4 Insight?

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

What is the FDA product code for Delta4 Insight?

The FDA product code for Delta4 Insight is IYE.

Other records listing Scandidos AB 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.

K183606Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)K151426ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

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

View on FDA Database →

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

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