| Primary Device ID | 09120105730730 |
| NIH Device Record Key | 79879554-7380-4a21-be92-1c3e6f3c5d0a |
| Commercial Distribution Discontinuation | 2026-07-19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IB Lab LAMA |
| Version Model Number | V1.06 |
| Company DUNS | 300512152 |
| Company Name | IB Lab GmbH |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 09120105730464 - KOALA | 2026-01-27 The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators |
| 09120105730730 - IB Lab LAMA | 2024-08-20IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied
upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology.
IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present. |
| 09120105730730 - IB Lab LAMA | 2024-08-20 IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb- |
| 09120105730471 - KOALA | 2022-01-19 The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators |
| 09120105730082 - KOALA | 2021-05-10 The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators |