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FDA 510(k)

MECALL CLISIS SYSTEMS, Discovery RF180

K-Number: K173395 · 2018-05-21

ApplicantGeneral Medical Merate S.P.A
Decision Date2018-05-21
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MECALL CLISIS SYSTEMS, Discovery RF180 is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Merate S.P.A. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K173395. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECALL CLISIS SYSTEMS, Discovery RF180?

MECALL CLISIS SYSTEMS, Discovery RF180 is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is General Medical Merate S.P.A. The 510(k) number is K173395.

When did MECALL CLISIS SYSTEMS, Discovery RF180 receive FDA 510(k) clearance?

MECALL CLISIS SYSTEMS, Discovery RF180 received FDA 510(k) clearance on 2018-05-21, under 510(k) number K173395.

Who is the listed applicant for MECALL CLISIS SYSTEMS, Discovery RF180?

The FDA 510(k) record lists General Medical Merate S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MECALL CLISIS SYSTEMS, Discovery RF180?

The FDA product code for MECALL CLISIS SYSTEMS, Discovery RF180 is JAA.

Other records listing General Medical Merate S.P.A 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.

K213081CLISIS SYSTEMS, Discovery RF180

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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