Jazz Imaging, LLC Dba Jazz Imaging

FDA Regulatory Profile

Jazz Imaging, LLC Dba Jazz Imaging has 0 FDA recalls, 3 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 1, 2026 · VAI
Latest 510(k)
Nov 21, 2024

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections3Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 1, 2026San Jose, CADevicesVoluntary Action Indicated (VAI)3013503781
Oct 24, 2022San Jose, CADevicesVoluntary Action Indicated (VAI)3013503781
Jul 26, 2019San Jose, CADevicesVoluntary Action Indicated (VAI)3013503781

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K241495Jazz ClassicNov 21, 2024
K213637JAZZ Solo sensorDec 10, 2021
K163224JAZZ SOLO SensorMar 9, 2017