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FDA 510(k)

iSchemaView RAPID

K-Number: K182130 · 2018-12-27

ApplicantIschemaview, Inc.
Decision Date2018-12-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iSchemaView RAPID is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2018-12-27 under approval number K182130. 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 iSchemaView RAPID?

iSchemaView RAPID is a medical device that received FDA 510(k) clearance on 2018-12-27. It is manufactured by Ischemaview, Inc.. The 510(k) number is K182130.

When was iSchemaView RAPID approved by the FDA?

iSchemaView RAPID received FDA 510(k) clearance on 2018-12-27, under approval number K182130.

What company makes iSchemaView RAPID?

iSchemaView RAPID is manufactured by Ischemaview, Inc..

What is the FDA product code for iSchemaView RAPID?

The FDA product code for iSchemaView RAPID is LLZ.

Other Devices by Ischemaview, Inc.

K172477iSchemaView RAPID K200941Rapid LVO K200760Rapid ASPECTS K221456Rapid ICH K221248Rapid LVO K220499Rapid PE Triage and Notification (PETN)

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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.

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