Surgimap®
Model 2.2.9.X · NEMARIS, INC · DI 00859699006042
LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 5 |
| 2019-02 | 0 | 11.5 |
| 2019-03 | 0 | 8.71 |
| 2019-04 | 0 | 7.44 |
| 2019-05 | 0 | 15.67 |
| 2019-06 | 0 | 11 |
| 2019-07 | 0 | 12.6 |
| 2019-08 | 0 | 24.67 |
| 2019-09 | 0 | 9.5 |
| 2019-10 | 0 | 9 |
| 2019-11 | 0 | 9.5 |
| 2019-12 | 0 | 13.67 |
| 2020-01 | 0 | 4.38 |
| 2020-02 | 0 | 10.4 |
| 2020-03 | 0 | 9.75 |
| 2020-04 | 0 | 14.75 |
| 2020-05 | 0 | 6 |
| 2020-06 | 0 | 2.6 |
| 2020-07 | 0 | 3.6 |
| 2020-08 | 0 | 3.38 |
| 2020-09 | 0 | 1.87 |
| 2020-10 | 0 | 3.22 |
| 2020-11 | 0 | 2.36 |
| 2020-12 | 0 | 3.4 |
| 2021-01 | 0 | 2.91 |
| 2021-02 | 0 | 3 |
| 2021-03 | 0 | 3.5 |
| 2021-04 | 0 | 3.5 |
| 2021-05 | 0 | 4 |
| 2021-06 | 0 | 3.08 |
| 2021-07 | 0 | 4.58 |
| 2021-08 | 0 | 4 |
| 2021-09 | 0 | 2.5 |
| 2021-10 | 0 | 3.58 |
| 2021-11 | 0 | 3.45 |
| 2021-12 | 0 | 4.5 |
| 2022-01 | 0 | 3.29 |
| 2022-02 | 0 | 2.8 |
| 2022-03 | 0 | 3.67 |
| 2022-04 | 0 | 2.15 |
| 2022-05 | 0 | 1.78 |
| 2022-06 | 0 | 4 |
| 2022-07 | 0 | 2.83 |
| 2022-08 | 0 | 2.7 |
| 2022-09 | 0 | 2.75 |
| 2022-10 | 0 | 3.33 |
| 2022-11 | 0 | 2.18 |
| 2022-12 | 0 | 2.13 |
| 2023-01 | 0 | 2.27 |
| 2023-02 | 0 | 2.42 |
| 2023-03 | 0 | 2.47 |
| 2023-04 | 0 | 2.28 |
| 2023-05 | 0 | 1.56 |
| 2023-06 | 0 | 2.85 |
| 2023-07 | 0 | 2.75 |
| 2023-08 | 0 | 2.11 |
| 2023-09 | 0 | 2.05 |
| 2023-10 | 0 | 3.58 |
| 2023-11 | 0 | 2.22 |
| 2023-12 | 0 | 1.91 |
| 2024-01 | 0 | 2.07 |
| 2024-02 | 0 | 2.76 |
| 2024-03 | 0 | 2.75 |
| 2024-04 | 0 | 4.72 |
| 2024-05 | 0 | 2.61 |
| 2024-06 | 0 | 2.58 |
| 2024-07 | 0 | 3.05 |
| 2024-08 | 0 | 3.33 |
| 2024-09 | 0 | 3.33 |
| 2024-10 | 0 | 3.42 |
| 2024-11 | 0 | 3.28 |
| 2024-12 | 0 | 2.28 |
| 2025-01 | 0 | 6.46 |
| 2025-02 | 0 | 6.95 |
| 2025-03 | 0 | 2.59 |
| 2025-04 | 0 | 2.5 |
| 2025-05 | 0 | 2.48 |
| 2025-06 | 0 | 2.89 |
| 2025-07 | 0 | 3.11 |
| 2025-08 | 0 | 4.05 |
| 2025-09 | 0 | 2.85 |
| 2025-10 | 0 | 9.4 |
| 2025-11 | 0 | 3.08 |
| 2025-12 | 0 | 6.56 |
| 2026-01 | 0 | 7.11 |
| 2026-02 | 0 | 4.38 |
| 2026-03 | 0 | 16.38 |
| 2026-04 | 0 | 12.28 |
| 2026-05 | 0 | 19.41 |
| 2026-06 | 0 | 10.38 |
Regulatory clearances
- K141669 SESE 2014-09-19 (k number procode)
Predicate lineage
K141669 — cites (transitively): K073714 (d1), K111019 (d1) — cited as predicate by K160407, K162647, K170172, K171617, K180091, K192435, K211987, K213975, K221796, K223841, K251532, K260322
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — NEMARIS, INC
Nothing in the loaded window.