RadLogics, Inc.

Warning LetterOpen

United StatesFEI 3012236091Issued Apr 5, 2018

View FDA's record for FEI 3012236091

Source: FDA warning letter records. FDA has not published the text of this letter. To check it, open FDA's record for this establishment, listed under FEI 3012236091.

Violations0

Issue DateApr 5, 2018

Product TypeOther

StatusOpen

Letter Details

Firm: RadLogics, Inc.
Location: United States
FEI Number: 3012236091
Country: United States
Issue Date: April 05, 2018
Issuing Office: N/A
Product Type: Other
Status: Open

Summary

Based on limited metadata, RadLogics, Inc. received an FDA Warning Letter dated April 5, 2018, regarding a product classified as "Other," indicating it does not fit standard device or drug categories. Without access to the full letter text or specific subject line details, the exact nature of the violations cannot be determined with certainty. The issuing office information is unavailable, which limits clarity on the specific regulatory division involved. To understand the precise regulatory concerns and required corrective actions, the complete Warning Letter document would be necessary.

RadLogics, Inc. FDA Warning Letter, April 5, 2018