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)

INREACH PLANNING LAPTOP

K-Number: K082386 · 2008-09-16

ApplicantSuperdimension, Ltd.
Decision Date2008-09-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INREACH PLANNING LAPTOP is the device name listed in this FDA 510(k) record. The listed applicant is Superdimension, Ltd.. It received FDA 510(k) clearance on 2008-09-16 under 510(k) number K082386. 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 INREACH PLANNING LAPTOP?

INREACH PLANNING LAPTOP is a medical device that received FDA 510(k) clearance on 2008-09-16. The listed applicant is Superdimension, Ltd.. The 510(k) number is K082386.

When did INREACH PLANNING LAPTOP receive FDA 510(k) clearance?

INREACH PLANNING LAPTOP received FDA 510(k) clearance on 2008-09-16, under 510(k) number K082386.

Who is the listed applicant for INREACH PLANNING LAPTOP?

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

What is the FDA product code for INREACH PLANNING LAPTOP?

The FDA product code for INREACH PLANNING LAPTOP is LLZ.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Superdimension, Ltd. 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.

K102604I-LOGIC INREACH SYSTEMK092365INREACH SYSTEM, MODEL AAS00161-02K081379MODIFICATION TO INREACH SYSTEMK080271INREACH SYSTEMK071473MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2K062315SUPERDIMENSION/BRONCHUS PREMIUM 2

View all 10 devices →

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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.

↑