Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K092467
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED · Brainlab AG · decided 2010-05-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Cranial Reference Array Drapelink | 19152-02 | Brainlab SE | HAW OLO | 04056481004545 |
| Ultrasound Registration Phantom | 22530-0A | Brainlab SE | HAW | 04056481004286 |
| Navigation SW Cranial EM | 1.1 | Brainlab SE | HAW | 04056481132422 |
| Guide 1.8 Biopsy UI | 55980-01 | Brainlab SE | HAW | 04056481094713 |
| Instr. Adapter Array (Starlink), Size Xl | 41802 | Brainlab SE | HAW OLO | 04056481006211 |
| Tube Biopsy Ui | 55970 | Brainlab SE | HAW | 04056481005092 |
| Curve™ | 19901 | Brainlab SE | HAW OLO | 04056481006365 |
| Registr. Matrix Imri Ge Headholder | 19202-20C | Brainlab SE | HAW | 04056481004477 |
| Mscope Adapter & Array Zeiss Opmi Vario | 41767-30A | Brainlab SE | HAW | 04056481003814 |
| Disp. Registration Marker Mr | 52151A | Brainlab SE | HAW | 04056481002435 |
| Mscope Adapter & Array Zeiss Opmi Neuro | 41767-60A | Brainlab SE | HAW | 04056481003753 |
| Navigation Software Cranial | 3.0 | Brainlab SE | HAW | 04056481138790 |
| Disposable Self-Tapping Screw | 52128 | Brainlab SE | HAW | 04056481006020 |
| Us- Adapter Siemens Sonoline C8-5 | 41860-24 | Brainlab SE | HAW | 04056481003005 |
| Headholder Clamp IOP Imaging | 19147-01A | Brainlab SE | HAW | 04056481114022 |
| Registration Software Cranial | 3.0 | Brainlab SE | HAW | 04056481138783 |
| INSTR ADAPTER CLAMP SIZE XL (Softgrip) | 55114 | Brainlab SE | OLO | 04056481141219 |
| Sterilizaiton Tray Em Pointer | 18099-18 | Brainlab SE | HAW | 04056481004828 |
| Pointer Tip (Offset 45°, Length 115 Mm) | 55791-02 | Brainlab SE | HAW | 04056481001384 |
| Ultrasound Clamp Hitachi Eup N532 | 41860-8 | Brainlab SE | HAW | 04056481002800 |
| Bl Pointer Straight-Extended | 52781A | Brainlab SE | HAW | 04056481002152 |
| Ultrasound Clamp Primus Eupc 321T | 41860-18 | Brainlab SE | HAW | 04056481003081 |
| INSTRUMENT ADAPTER EXTENSION 50 MM | 55016 | Brainlab SE | OLO | 04056481142209 |
| Bl Pointer Straight-Extended | 52781 | Brainlab SE | HAW | 04056481005788 |
| Base Short For Drapelink | 19153-04 | Brainlab SE | HAW OLO | 04056481004507 |