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FDA PRODUCT CODE · CLASS III

SHH — Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer

Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy).

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES

Recent clearances

P250008Perimeter Medical Imaging Ai, Inc. · pma2026-03-03

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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