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FDA 510(k)

RayCare 2.3

K-Number: K191384 · 2019-07-08

ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2019-07-08
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RayCare 2.3 is the device name listed in this FDA 510(k) record. The listed applicant is RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K191384. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RayCare 2.3?

RayCare 2.3 is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is RaySearch Laboratories AB (PUBL). The 510(k) number is K191384.

When did RayCare 2.3 receive FDA 510(k) clearance?

RayCare 2.3 received FDA 510(k) clearance on 2019-07-08, under 510(k) number K191384.

Who is the listed applicant for RayCare 2.3?

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

What is the FDA product code for RayCare 2.3?

The FDA product code for RayCare 2.3 is MUJ.

Other records listing RaySearch Laboratories AB (PUBL) 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.

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Related Devices (Code: MUJ)

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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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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