FDA 510(k)

CAS-One IR

K-Number: K232022 · 2024-03-13

Decision Date2024-03-13

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CAS-One IR is the device name listed in this FDA 510(k) record. The listed applicant is Cascination AG. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K232022. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAS-One IR?

CAS-One IR is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Cascination AG. The 510(k) number is K232022.

When did CAS-One IR receive FDA 510(k) clearance?

CAS-One IR received FDA 510(k) clearance on 2024-03-13, under 510(k) number K232022.

Who is the listed applicant for CAS-One IR?

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

What is the FDA product code for CAS-One IR?

The FDA product code for CAS-One IR is JAK.

Other records listing Cascination AG 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.

K242120OTOPLAN K220300OTOPLAN K203486Otoplan K152473CAS-One IR

Related Devices (Code: JAK)

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, LLC K253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

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.