FDA applicant
Cti Pet Systems, Inc.
FDA records 19 decisions for Cti Pet Systems, Inc. (Knoxville, TN) from 1991 to 2005: 19 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and LLZ (System, Image Processing, Radiological). Its devices cite 21 predicates, 17 of them its own earlier devices. 17 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cti Pet Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cti Pet Systems, Inc. since 2007.
Recalls per year
12in 2007
Class I Class II/III not classified
Planning a device like Cti Pet Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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