FDA 510(k)

APLIO ARTIDA V2.0 SSH-880CV

K-Number: K090158 · 2009-02-06

ApplicantToshiba America Medical Systems, In.C

Decision Date2009-02-06

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

APLIO ARTIDA V2.0 SSH-880CV is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K090158. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APLIO ARTIDA V2.0 SSH-880CV?

APLIO ARTIDA V2.0 SSH-880CV is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K090158.

When did APLIO ARTIDA V2.0 SSH-880CV receive FDA 510(k) clearance?

APLIO ARTIDA V2.0 SSH-880CV received FDA 510(k) clearance on 2009-02-06, under 510(k) number K090158.

Who is the listed applicant for APLIO ARTIDA V2.0 SSH-880CV?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APLIO ARTIDA V2.0 SSH-880CV?

The FDA product code for APLIO ARTIDA V2.0 SSH-880CV is IYN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Toshiba America Medical Systems, In.C as applicant

K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWARE K131822ULTRAEXTEND USWS-900A V2.1 AND V3.1 K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS801 K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US K121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE K122842RADREX-I, SW V4.00 MODEL DRAD-3000E

View all 143 devices →

Related Devices (Code: IYN)

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.