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FDA 510(k)

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

K-Number: K183606 · 2019-04-08

ApplicantScandidos AB
Decision Date2019-04-08
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is the device name listed in this FDA 510(k) record. The listed applicant is Scandidos AB. It received FDA 510(k) clearance on 2019-04-08 under 510(k) number K183606. 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 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is a medical device that received FDA 510(k) clearance on 2019-04-08. The listed applicant is Scandidos AB. The 510(k) number is K183606.

When did Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) receive FDA 510(k) clearance?

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) received FDA 510(k) clearance on 2019-04-08, under 510(k) number K183606.

Who is the listed applicant for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

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 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

The FDA product code for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) 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.

K223234Delta4 InsightK151426ScandiDos 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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