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FDA 510(k)

DELTA4

K-Number: K052920 · 2006-01-12

ApplicantScandidos AB
Decision Date2006-01-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DELTA4 is the device name listed in this FDA 510(k) record. The listed applicant is Scandidos AB. It received FDA 510(k) clearance on 2006-01-12 under 510(k) number K052920. 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?

DELTA4 is a medical device that received FDA 510(k) clearance on 2006-01-12. The listed applicant is Scandidos AB. The 510(k) number is K052920.

When did DELTA4 receive FDA 510(k) clearance?

DELTA4 received FDA 510(k) clearance on 2006-01-12, under 510(k) number K052920.

Who is the listed applicant for DELTA4?

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?

The FDA product code for DELTA4 is IYE.

Related Clinical Trials

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.

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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 InsightK183606Delta4 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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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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