FDA 510(k) clearance · back to tracker
HyperVue Imaging System - Integrated
Spectrawave, Inc. cleared K253101 on 2025-12-15, decision: substantially equivalent
K-number
K253101
Sponsor
Spectrawave, Inc.
Device
HyperVue Imaging System - Integrated
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-12-15
Product code
NQQ
Advisory committee
Radiology
Medical specialty
Radiology
Regulation number
892.1560
Official FDA record
Open K253101on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.