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FDA 510(k)

AS-10

K-Number: K200887 · 2020-04-15

ApplicantCanon, Inc.
Decision Date2020-04-15
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AS-10 is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2020-04-15 under 510(k) number K200887. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AS-10?

AS-10 is a medical device that received FDA 510(k) clearance on 2020-04-15. The listed applicant is Canon, Inc.. The 510(k) number is K200887.

When did AS-10 receive FDA 510(k) clearance?

AS-10 received FDA 510(k) clearance on 2020-04-15, under 510(k) number K200887.

Who is the listed applicant for AS-10?

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

What is the FDA product code for AS-10?

The FDA product code for AS-10 is OWB.

Other records listing Canon, 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.

K252503Intelligent NRK241049CANON Fundus Camera CR-10 (CR-10)K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlK230175Digital Radiography CXDI-CS01K222855Digital Radiography CXDI-Pro, Digital Radiography D1K222687Digital Radiography CXDI-Elite, Digital Radiography E1

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Related Devices (Code: OWB)

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.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.

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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