Origin Data Management / Patient Data Manager
2 catalogue numbers from 2.3.1, listed by Brainlab SE, Germany, under Digitizer, Image, Radiological. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Microtek Computer Technology (Wu Jiang) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Brainlab SE, Germany |
|---|---|
| FDA product code | LMA |
| Device type | Digitizer, Image, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2030 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-01-02 |
| Record revised | 2025-09-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Distribution end date | 2022-12-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.3.1 | Withdrawn | |
| 2.3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vidar Systems Corporation | Vidar Systems Corp. | 10 |
| 3600 | iCRco Inc. | 2 |
| Radlink Laser Pro 16 | Radlink, Inc. | 1 |
| Chrome | iCRco Inc. | 1 |
| iDR | iCRco Inc. | 1 |
| MDR Video | Hyland LLC | 1 |
| Patient Data Manager 2.4 Installer | Brainlab SE | 1 |
| Dicom Box | Hyland LLC | 1 |
| Patient Data Manager | Brainlab SE | 1 |
| MDR Video Touch | Hyland LLC | 1 |
| MDR Video Cart | Hyland LLC | 1 |
| MDR Video Speech | Hyland LLC | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Brainlab SE | UDI-DI | 2019-09-25 | Class II | Software design | The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3. | 1230 units | 2024-03-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.