<p>Purpose: To investigate the characteristics of suspicious MRI-only visible lesions and to explore the validity of subcategorizing these lesions into the following two groups: lesions that would require immediate biopsy (4Bi) and lesions for which careful clinical follow-up could be recommended (4Fo).</p><p>Methods: A retrospective review of 108 MRI-only visible lesions in 106 patients who were diagnosed as Breast Imaging Reporting and Data System (BI-RADS) category 4 between June 2018 and June 2022 at our institution was performed by two radiologists. The breast MR images were evaluated according to BI-RADS and additional MRI descriptors (linear ductal, branching, and apparent diffusion coefficient values). The lesions were categorized by previously reported classification systems, and the positive predictive values (PPVs) for the different categories were determined and compared. Subsequently, a new classification system was developed in this study.</p><p>Results: The total malignancy rate was 31% (34/108). No significant differences between benign and malignant lesions were identified for focus and mass lesions. For non-mass lesions, linear ductal and heterogeneous internal enhancement suggested a benign lesion (P = 0.0013 and P = 0.023, respectively), and branching internal enhancement suggested malignancy (P = 0.0066). Segmental distribution suggested malignancy (P = 0.0097). However, the PPV of segmental distribution with heterogeneous enhancement was significantly lower than that of category 4 segmental lesions with other enhancement patterns (11% vs. 59%; P = 0.0198).</p><p>As a new classification, the distribution of focal, linear, and segmental was given a score of 0, 1, or 2, and the internal enhancement of heterogeneous, linear-ductal, clumped, branching, and clustered-ring enhancement was given a score of 0, 1, 2, 3, and 4, respectively. When categorized using a scoring system, a statistically significant difference in PPV was observed between 4Fo (n = 27) and 4Bi (n = 33) (7% vs. 61%, P = 0.000029).</p><p>Conclusion: The new classification system was found to be highly capable of subcategorizing BI-RADS category 4 MRI-only visible non-mass lesions into 4Fo and 4Bi.</p>