FDA 510(k)

Histolog® Scanner (Hardware 2.4, Software 3.3)

K-Nummer: K241275 · 2024-08-19

Entscheidungsdatum2024-08-19

ProduktcodeOWN

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

Histolog® Scanner (Hardware 2.4, Software 3.3) is the device name listed in this FDA 510(k) record. The listed applicant is Samantree Medical SA. It received FDA 510(k) clearance on 2024-08-19 under 510(k) number K241275. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Histolog® Scanner (Hardware 2.4, Software 3.3)?

Histolog® Scanner (Hardware 2.4, Software 3.3) is a medical device that received FDA 510(k) clearance on 2024-08-19. The listed applicant is Samantree Medical SA. The 510(k) number is K241275.

When did Histolog® Scanner (Hardware 2.4, Software 3.3) receive FDA 510(k) clearance?

Histolog® Scanner (Hardware 2.4, Software 3.3) received FDA 510(k) clearance on 2024-08-19, under 510(k) number K241275.

Who is the listed applicant for Histolog® Scanner (Hardware 2.4, Software 3.3)?

The FDA 510(k) record lists Samantree Medical SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Histolog® Scanner (Hardware 2.4, Software 3.3)?

The FDA product code for Histolog® Scanner (Hardware 2.4, Software 3.3) is OWN.

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Verwandte Geräte (Code: OWN)

K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG

Offizielle Quelle

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