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)

SKOUT Software

K-Number: K213686 · 2022-08-12

ApplicantIterative Scopes, Inc.
Decision Date2022-08-12
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SKOUT Software is the device name listed in this FDA 510(k) record. The listed applicant is Iterative Scopes, Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K213686. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKOUT Software?

SKOUT Software is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Iterative Scopes, Inc.. The 510(k) number is K213686.

When did SKOUT Software receive FDA 510(k) clearance?

SKOUT Software received FDA 510(k) clearance on 2022-08-12, under 510(k) number K213686.

Who is the listed applicant for SKOUT Software?

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

What is the FDA product code for SKOUT Software?

The FDA product code for SKOUT Software is QNP.

Other records listing Iterative Scopes, Inc. 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.

K241508SKOUT® systemK240781SKOUT® systemK230658SKOUT® system

Related Devices (Code: QNP)

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.

K260567EW10-EC02 Endoscopy Support ProgramFujifilm CorporationK252853CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd.K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.K260724MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.K253664SKOUT systemIterative HealthK252178MAGENTIQ-COLO (ME-APDS)Magentiq Eye, 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.

↑