Micromate? Navi+
Isys Medizintechnik GmbH
ISYS Medizintechnik GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013035022 | 3013035022 | ISYS Medizintechnik GmbH | 1 | N | 2026-01-01 | Bergwerksweg 21 Kitzbuehel Salzburg AT 6370 |
| 3013847349 | 3013847349 | iSYS Medizintechnik GmbH | 1 | N | 2026-01-01 | Ulrichstrasse 40 Untermeitingen Bavaria DE 86836 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 195580 | 1145323027 | K230130 | Micromate™ Navi+ | JAK | 2023-10-10 |
| 299531 | 1145323027 | K230130 | Micromate™ Navi+ | JAK | 2023-10-10 |
| 195580 | 1068798990 | K203720 | MICROMATE | JAK | 2021-06-22 |
| 299531 | 1068798990 | K203720 | MICROMATE | JAK | 2021-06-22 |
| 195580 | 1823512199 | K131433 | ISYS 1 (U.S),ACCESSORY, NON-STERILE | JAK | 2014-03-11 |
| 195580 | 1555574206 | ||||
| 299531 | 1555574206 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JAK | 5 | 2023-10-10 |
PMN#
MICROMATE
Isys Medizintechnik GmbH
ISYS 1 (U.S),ACCESSORY, NON-STERILE
ISYS MEDIZINTECHNIK GMBH
GUDID#
Micromate Navi+ - The Micromate™ Navi+ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined by an internal planning and navigation software (MicroNav). The alignment to the surgical plan is performed through a manual gross-positioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as optical CT navigation (tracked by camera). After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the user, while the position is retained by the targeting platform of Micromate™ Navi+, relying on the displayed navigation information or real-time images from third party imaging device.The Micromate™ Navi+ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of surgical instruments in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device.
2024-02-26
Micromate - The intended use of the Micromate™ device is to function as a remote-operated positioning and guidance system during interventional procedures. Positioning is done in a remote-controlled manner; planning of the position/angulation is done based on 2D/3D patient data (CT, cone-beam CT, fluoroscopy) by external/internal planning software – for example using an image-guided navigation system or external/internal navigation system, or planning software coming with the used imaging device.Also, verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of these external devices. The Micromate™ system is then acting as a guideway during the manual insertion of the interventional tool – usually a needle type device, and the like - through a third-party needle guide, manufactured by Exact MM (K101689): P/N E2178 (Micromate Needle Guide Set, 8-11G), P/N E2183 (Micromate Needle Guide Set,10-14G) and P/N E2184 (Micromate Needle Guide Set, 15-21G). During operation, the device is covered with a sterile drape, which is part of the P/N2178, P/N E2183 and E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact MM (K101689): P/N 11718EU (Micromate Control Unit Drape). Applications include, but are not limited to, interventions like biopsy procedures, tumor ablation, nerve blocking, electrode placement, etc.
2023-09-06
iFIX - Designed for connection with operating tables, contains a side-rail adapter portion (to fit US side-rails) and a flat plastic portion to which a standard iFIX Patch with custom size is attached. Ideal for interventions and surgery, where tables often exhibit a side-rail at different patient heights and allow a strong and clean fixation of equipment, including the iFIX Side-Rail Adapter.
2024-07-30
iFIX - Designed for connection with operating tables, contains a side-rail adapter portion (to fit JP side-rails) and a flat plastic portion to which a standard iFIX Patch with custom size is attached. Ideal for interventions and surgery, where tables often exhibit a side-rail at different patient heights and allow a strong and clean fixation of equipment, including the iFIX Side-Rail Adapter.
2024-07-30
iFIX - iFIX Tray is a extremity support product, a part of iFIX Arm Rest. It is a long top surface capable of fitting the PearlFit Cushion 50x20x4 (P/N 1124-A) for patient comfort.
2024-07-30
iFIX - The iFIX Canon Aquilioin Adapter is a non-sterile product which allows to attach a Slot Adapter 3.0/30 to a table T-Slot (for all Canon CT tables including version 2020).
2024-07-30
iFIX - Designed for connection with operating tables, contains a side-rail adapter portion (to fit US side-rails) and a flat plastic portion to which a standard iFIX Patch with custom size is attached. Ideal for interventions and surgery, where tables often exhibit a side-rail at different patient heights and allow a strong and clean fixation of equipment, including the iFIX Side-Rail Adapter.
2024-07-30
iFIX - Designed for connection with operating tables, contains a side-rail adapter portion (to fit JP side-rails) and a flat plastic portion to which a standard iFIX Patch with custom size is attached. Ideal for interventions and surgery, where tables often exhibit a side-rail at different patient heights and allow a strong and clean fixation of equipment, including the iFIX Side-Rail Adapter.
2024-07-30
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization
2021-07-01
iFIX - short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2019-03-31
iFIX - Short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2019-11-08
iFIX - Short-term patient stabilization device
2020-05-04
iFIX - Short-term patient stabilization device
2020-05-04
iFIX - short-term patient stabilization device
2019-03-31
iFIX - short-term patient stabilization device
2020-05-04
iFIX - Short-term patient stabilization device
2020-05-04
iFIX - Short-term patient stabilization device
2020-05-04
iFIX - Short-term patient stabilization device
2020-05-04
iFIX - Short-term patient stabilization device
2020-05-04