Brit Systems, Inc.

FDA Regulatory Profile

Brit Systems, Inc. has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 31, 2025 · NAI
Latest 510(k)
Mar 23, 2009

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 31, 2025Wallingford, CTDevicesNo Action Indicated (NAI)1000306093
Sep 1, 2017Wallingford, CTDevicesVoluntary Action Indicated (VAI)1000306093

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 1000306093Wallingford, CT2Oct 31, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K081168BRIT PACS SYSTEMSMar 23, 2009
K943383IMAGING WORKBENCHNov 22, 1994

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.