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)

In Reach

K-Number: K170789 · 2017-05-05

ApplicantCurvebeam, LLC
Decision Date2017-05-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

In Reach is the device name listed in this FDA 510(k) record. The listed applicant is Curvebeam, LLC. It received FDA 510(k) clearance on 2017-05-05 under 510(k) number K170789. 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 In Reach?

In Reach is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Curvebeam, LLC. The 510(k) number is K170789.

When did In Reach receive FDA 510(k) clearance?

In Reach received FDA 510(k) clearance on 2017-05-05, under 510(k) number K170789.

Who is the listed applicant for In Reach?

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

What is the FDA product code for In Reach?

The FDA product code for In Reach is JAK.

Other records listing Curvebeam, LLC 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.

K241713HiRise (1040-230)K203187HiRiseK181962CubeVueK180727LineUp

Related Devices (Code: JAK)

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral 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.

↑