TBS iNsight— 510(k) K152299
Substantially EquivalentMedimaps Group SA
FDA 510(k) clearance K152299 for TBS iNsight, Substantially Equivalent on 2016-04-29. Applicant: Medimaps Group SA. Device class: 2.
Clearance details
- Applicant
- Medimaps Group SA
- Product code
- Code KGI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1170
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plan Les Ouates, CH
Recent devices under product code KGI
view allMore clearances from Medimaps Group SA
view allAdverse events under product code KGI
product code KGI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K152299
K-number listed on FDA's recall record- Z-1250-2025 — Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No
- Z-0369-2017 — TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152299.
Data sourced from openFDA. This site is unofficial and independent of the FDA.