4 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 4, 2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026