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FDA 510(k)

iSchemaView RAPID

K-Number: K172477 · 2018-04-19

ApplicantIschemaview, Inc.
Decision Date2018-04-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iSchemaView RAPID is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K172477. 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 2018-04-19. The listed applicant is Ischemaview, Inc.. The 510(k) number is K172477.

When did iSchemaView RAPID receive FDA 510(k) clearance?

iSchemaView RAPID received FDA 510(k) clearance on 2018-04-19, under 510(k) number K172477.

Who is the listed applicant for iSchemaView RAPID?

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

What is the FDA product code for iSchemaView RAPID?

The FDA product code for iSchemaView RAPID is LLZ.

Other records listing Ischemaview, Inc. as applicant

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Related Devices (Code: LLZ)

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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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