The following data is part of a premarket notification filed by Brainlab Ag with the FDA for 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.
| Device ID | K192703 |
| 510k Number | K192703 |
| Device Name: | 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 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Chiara Cunico |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481142650 | K192703 | 000 |
| 04056481004774 | K192703 | 000 |
| 04056481144166 | K192703 | 000 |
| 04056481144173 | K192703 | 000 |
| 04056481145224 | K192703 | 000 |
| 04056481145231 | K192703 | 000 |
| 04056481145248 | K192703 | 000 |
| 04056481146405 | K192703 | 000 |
| 04056481002503 | K192703 | 000 |
| 04056481006051 | K192703 | 000 |
| 04056481006297 | K192703 | 000 |
| 04056481002459 | K192703 | 000 |
| 04056481002473 | K192703 | 000 |
| 04056481143503 | K192703 | 000 |
| 04056481142414 | K192703 | 000 |
| 04056481145514 | K192703 | 000 |