FDA 510(k)

IC-Flow™ Imaging System 2.0

Номер K: K243645 · 2025-09-22

Дата решения2025-09-22

Код продуктаIZI

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

IC-Flow™ Imaging System 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Green GmbH. It received FDA 510(k) clearance on 2025-09-22 under 510(k) number K243645. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the IC-Flow™ Imaging System 2.0?

IC-Flow™ Imaging System 2.0 is a medical device that received FDA 510(k) clearance on 2025-09-22. The listed applicant is Diagnostic Green GmbH. The 510(k) number is K243645.

When did IC-Flow™ Imaging System 2.0 receive FDA 510(k) clearance?

IC-Flow™ Imaging System 2.0 received FDA 510(k) clearance on 2025-09-22, under 510(k) number K243645.

Who is the listed applicant for IC-Flow™ Imaging System 2.0?

The FDA 510(k) record lists Diagnostic Green GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IC-Flow™ Imaging System 2.0?

The FDA product code for IC-Flow™ Imaging System 2.0 is IZI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: IZI)

K261037Система портативного ручного сканирования 780 nm SPY (SPY-PHI)Stryker Endoscopy K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.

Официальный источник

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