Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

eRAD PACS

K-Number: K241223 · 2024-10-31

ApplicantErad, Inc.
Decision Date2024-10-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

eRAD PACS is the device name listed in this FDA 510(k) record. The listed applicant is Erad, Inc.. It received FDA 510(k) clearance on 2024-10-31 under 510(k) number K241223. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eRAD PACS?

eRAD PACS is a medical device that received FDA 510(k) clearance on 2024-10-31. The listed applicant is Erad, Inc.. The 510(k) number is K241223.

When did eRAD PACS receive FDA 510(k) clearance?

eRAD PACS received FDA 510(k) clearance on 2024-10-31, under 510(k) number K241223.

Who is the listed applicant for eRAD PACS?

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

What is the FDA product code for eRAD PACS?

The FDA product code for eRAD PACS is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, 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.

↑