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FDA 510(k)

CFP-3131, CFP-2222

K-Number: K201172 · 2020-05-29

ApplicantMx Imaging, Inc.
Decision Date2020-05-29
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CFP-3131, CFP-2222 is the device name listed in this FDA 510(k) record. The listed applicant is Mx Imaging, Inc.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K201172. 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 CFP-3131, CFP-2222?

CFP-3131, CFP-2222 is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Mx Imaging, Inc.. The 510(k) number is K201172.

When did CFP-3131, CFP-2222 receive FDA 510(k) clearance?

CFP-3131, CFP-2222 received FDA 510(k) clearance on 2020-05-29, under 510(k) number K201172.

Who is the listed applicant for CFP-3131, CFP-2222?

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

What is the FDA product code for CFP-3131, CFP-2222?

The FDA product code for CFP-3131, CFP-2222 is OWB.

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

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