|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
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alignment system cranial, alignment software cranial, cirq alignment software cranial biopsy, cirq alignment software cranial seeg, varioguide alignment software cranial
|
Brainlab AG
|
K223864 |
09/09/2023
|
cranial navigation, navigation software cranial, navigation software craniofacial, cranial em system, automatic registration imri
|
Brainlab AG
|
K223288 |
07/21/2023
|
ent em
|
Brainlab AG
|
K223734 |
04/27/2023
|
brainlab elements – trajectory planning (2.6), elements stereotaxy, elements lead localization, elements trajectory planning cranial
|
Brainlab AG
|
K223552 |
04/19/2023
|
cranial em system
|
Brainlab AG
|
K213989 |
09/08/2022
|
cirq, cirq robotic alignment system, cirq robotic alignment module cranial, cirq robotic alignment module, cirq robotic alignment cranial and spine, cirq robotic alignment cranial and spine system
|
Brainlab AG
|
K210989 |
11/12/2021
|
trajectory planning, elements trajectory planning, elements lead localization
|
Brainlab AG
|
K211544 |
11/03/2021
|
disposable pre-calibrated suction
|
Brainlab AG
|
K201752 |
01/29/2021
|
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
|
K192703 |
10/08/2020
|
microscope navigation
|
Brainlab AG
|
K190250 |
09/06/2019
|
|