3C-Medical Intelligence GmbH
Landsberg am Lech Bavaria, DE
3C-Medical Intelligence GmbH appears in FDA device records in Landsberg am Lech Bavaria, DE. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to 3C-Medical Intelligence GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medical Intelligence Medizintechnik GmbH510(k), enforcement report, recall
510(k) clearance history
FDA records hold 8 510(k) clearances for 3C-Medical Intelligence GmbH between 2002 and 2015. The busiest year on record is 2007, with 2. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2007 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K143485 | iGuide 2.1 | IYE | Substantially Equivalent | |
| K121530 | BODYFIX SYSTEM | IYE | Substantially Equivalent | |
| K112210 | FRAXION | IYE | Substantially Equivalent | |
| K072898 | HEXAPOD EVO RT COUCH TOP | JAI | Substantially Equivalent | |
| K071870 | HEXAPOD RT COUCH TOP | JAI | Substantially Equivalent | |
| K041448 | HEXAPOD RT COUCHTOP | JAI | Substantially Equivalent | |
| K030439 | HEADFIX | IYE | Substantially Equivalent | |
| K013391 | BODYFIX | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710332 | 3003251135 | 3C-Medical Intelligence GmbH | 3C-Ring 1, Landsberg am Lech Bavaria 86899 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2082-2019 | IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. | Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain