Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K192703
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update · Brainlab AG · decided 2020-10-08 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ULTRASOUND NAVIGATION ADAPTER (BK N13C5) | 41860-40A | Brainlab SE | HAW | 04056481144173 |
| Cranial Reference Array Drapelink | 19152-02 | Brainlab SE | HAW OLO | 04056481004545 |
| 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 |
| Us- Adapter Siemens Sonoline C8-5 | 41860-24 | Brainlab SE | HAW | 04056481003005 |
| DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE M) (3 PCS) | 41860-45 | Brainlab SE | HAW | 04056481144456 |
| Pointer Tip (Offset 45°, Length 115 Mm) | 55791-02 | Brainlab SE | HAW | 04056481001384 |
| Base Short For Drapelink | 19153-04 | Brainlab SE | HAW OLO | 04056481004507 |
| Instr. Adapter Array (Starlink), Size Ml | 41799 | Brainlab SE | HAW OLO | 04056481006235 |
| Z-Touch Rev2 | 18370-10 | Brainlab SE | HAW | 04056481004798 |
| Registration Software Cranial | 3.5 | Brainlab SE | HAW | 04056481140687 |
| Us Adapter Acuson P9-4 | 41860-28 | Brainlab SE | HAW | 04056481002961 |
| Instr. Adp Offset-Link 45° 20Mm Starlink | 55013 | Brainlab SE | HAW OLO | 04056481005375 |
| Cranial/ENT | 3.1 | Brainlab SE | HAW | 04056481132439 |
| V-Inset Ge Headholder Kit | 52006 | Brainlab SE | HAW | 04056481006037 |
| Ultrasound Clamp B&K 8547 | 41860-9 | Brainlab SE | HAW | 04056481002794 |
| Pointer Tip (Offset 0°, Length 150 Mm) | 55791-01 | Brainlab SE | HAW | 04056481001391 |
| Instr Adapt Clamp (Starlink), Size S | 55101 | Brainlab SE | HAW OLO | 04056481005351 |
| Ultrasound Clamp Aloka Ust 995-7.5 | 41860-10A | Brainlab SE | HAW | 04056481003159 |
| Ultra Sound Clamp Hitachi Eupf 331 | 41860-11 | Brainlab SE | HAW | 04056481003142 |
| Calibration Phantom Ict | 19148-01A | Brainlab SE | HAW OLO | 04056481004569 |
| Suction Fs L (Ch 10) Starlink Frazier | 55790-35 | Brainlab SE | HAW | 04056481001490 |
| Starlink Suction Tube Frazier-Tip 45° Angled 10 FR | 55790-70 | Brainlab SE | HAW PGW | 04056481001421 |
| Starlink Suction Tube Frazier-Tip 70° Angled 8 FR | 55790-55 | Brainlab SE | HAW PGW | 04056481001452 |