Geniant Cranial
Geniant Cranial combines image navigation with a robot arm that positions instrument holders or guides for neurosurgery. CT or MR images support anatomical views, three-dimensional models…
Geniant Cranial combines image navigation with a robot arm that positions instrument holders or guides for neurosurgery. CT or MR images support anatomical views, three-dimensional models and planned surgical routes.
During a procedure, the system tracks compatible instruments and displays their positions relative to the patient images and saved plan. An infrared navigation camera and robot-arm encoders provide localization information.
Listed Item
Navigated Neurosurgical Positioning Robot
Guide Positioning
The system can adjust an instrument guide position automatically. The surgeon then carries out the surgical action through that guide using a compatible instrument. Patient registration relates the images to anatomy using methods such as anatomical points or skin and bone fiducial markers.
5manufacturers in China registered for this device type
113catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Sinovation (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | KOH Young Technology Inc., South Korea |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K241333 |
| Record published | 2025-02-20 |
| Record revised | 2025-07-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Sizes | Lumen/inner diameter 1.8 to 3.2 mm; length 30 to 85 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M_MN30-CSDB000 | In distribution | |
| M_MN30-PSA0000 | In distribution | |
| MN30-KH00002 | In distribution | |
| MN30-KF00060 | Length 60 mm | In distribution |
| M_MN30-CMRN000 | In distribution | |
| M_MN30-CLLC000 | In distribution | |
| MN30-KF00075 | Length 75 mm | In distribution |
| MN30-KF00055 | Length 55 mm | In distribution |
| MN30-KH00014 | In distribution | |
| MN30-KH00012 | In distribution | |
| M_MN30-CML0000 | In distribution | |
| M_MN30-CRMT000 | In distribution | |
| M_MN30-PSN0000 | In distribution | |
| MN30-CRGB320 | Lumen/Inner Diameter 3.2 mm | In distribution |
| MN30-CRGB245 | Lumen/Inner Diameter 2.45 mm | In distribution |
| MN30-KH00011 | In distribution | |
| MN30-CRGB250 | Lumen/Inner Diameter 2.5 mm | In distribution |
| MN30-KH00003 | In distribution | |
| KY-SMS-0030-B | In distribution | |
| M_MN30-CNT0000 | In distribution | |
| M_MN30-CNAB000 | In distribution | |
| MN30-KH00009 | In distribution | |
| MN30-KF00085 | Length 85 mm | In distribution |
| M_MN30-CNAM000 | In distribution | |
| MN30-KF00050 | Length 50 mm | In distribution |
| MN30-KH00010 | In distribution | |
| M_MN30-KW00000 | In distribution | |
| MN30-KH00013 | In distribution | |
| KY-CON-0030-A | In distribution | |
| M_MN30-CMA0000 | In distribution | |
| M_MN30-CSDA000 | In distribution | |
| M_MN30-CRG0000 | In distribution | |
| MN30-KH00007 | In distribution | |
| MN30-CNGB210 | Lumen/Inner Diameter 2.1 mm | In distribution |
| MN30-CNGK002 | In distribution | |
| MN30-KF00040 | Length 40 mm | In distribution |
| KY-PPM-0030-A | In distribution | |
| M_MN30-CMB0000 | In distribution | |
| M_MN30-PS00000 | In distribution | |
| MN30-CAM0001 | In distribution | |
| M_MN30-CMQ0000 | In distribution | |
| M_MN30-CMU0000 | In distribution | |
| M_MN30-KFS0000 | In distribution | |
| M_MN30-CRPT000 | In distribution | |
| MN30-KF00070 | Length 70 mm | In distribution |
| MN30-CRGB180 | Lumen/Inner Diameter 1.8 mm | In distribution |
| M_MN30-CMR0000 | In distribution | |
| M_MN30-KHC0000 | In distribution | |
| MN30-KH00015 | In distribution | |
| MN30-CRSC003 | In distribution | |
| MN30-CNGK001 | In distribution | |
| MN30-CNGB250 | Lumen/Inner Diameter 2.5 mm | In distribution |
| M_MN30-CMS0000 | In distribution | |
| MN30-CRAB025 | Lumen/Inner Diameter 2.5 mm | In distribution |
| MN30-CRGB220 | Lumen/Inner Diameter 2.2 mm | In distribution |
| KY-PWS-0030-B | In distribution | |
| M_MN30-CMF0000 | In distribution | |
| M_MN30-CRN0000 | In distribution | |
| M_MN30-KP00000 | In distribution | |
| MN30-CRAB018 | Lumen/Inner Diameter 1.8 mm | In distribution |
| M_MN30-CMAN000 | In distribution | |
| KY-NAC-0030-A | In distribution | |
| MN30-KF00035 | Length 35 mm | In distribution |
| MN30-CRAB210 | Lumen/Inner Diameter 2.1 mm | In distribution |
| M_MN30-CMH0000 | In distribution | |
| MN30-CNGK003 | In distribution | |
| MN30-KF00065 | Length 65 mm | In distribution |
| M_MN30-CRA0000 | In distribution | |
| M_601090-000045 | In distribution | |
| M_MN30-KFT0000 | In distribution | |
| MN30-CNG0001 | In distribution | |
| MN30-CRGB210 | Lumen/Inner Diameter 2.1 mm | In distribution |
| M_MN30-CNPT000 | In distribution | |
| MN30-CRS0002 | In distribution | |
| M_MN30-QC00000 | In distribution | |
| KY-ROT-0030-A | In distribution | |
| MN30-KH00001 | In distribution | |
| KY-BGS-0030-B | In distribution | |
| M_MN30-CMM0000 | In distribution | |
| M_MN30-CMV0000 | In distribution | |
| M_MN30-CNGR000 | In distribution | |
| M_MN30-K000000 | In distribution | |
| M_MN30-CNAA000 | In distribution | |
| M_MN30-CMP0000 | In distribution | |
| MN30-KF00080 | Length 80 mm | In distribution |
| MN30-CRAB250 | Lumen/Inner Diameter 2.5 mm | In distribution |
| M_MN30-PC00000 | In distribution | |
| MN30-CRSC004 | In distribution | |
| M_MN30-CRGR000 | In distribution | |
| MN30-KF00045 | Length 45 mm | In distribution |
| MN30-KH00006 | In distribution | |
| MN30-CNGB220 | Lumen/Inner Diameter 2.2 mm | In distribution |
| M_MN30-CME0000 | In distribution | |
| M_MN30-CNMT000 | In distribution | |
| M_MN30-CRT0000 | In distribution | |
| KY-PPR-0030-A | In distribution | |
| MN30-CRS0001 | In distribution | |
| MN30-KF00030 | Length 30 mm | In distribution |
| M_MN30-CMD0000 | In distribution | |
| MN30-KH00004 | In distribution | |
| M_MN30-CMG0000 | In distribution | |
| MN30-KH00008 | In distribution | |
| M_MN30-CRW0000 | In distribution | |
| MN30-CRAB021 | Lumen/Inner Diameter 2.1 mm | In distribution |
| MN30-CRAB180 | Lumen/Inner Diameter 1.8 mm | In distribution |
| MN30-CRSC001 | In distribution | |
| M_MN30-CMC0000 | In distribution | |
| M_MN30-CNAP000 | In distribution | |
| MN30-CRSC002 | In distribution | |
| MN30-CRGB001 | In distribution | |
| M_MN30-CLL0000 | In distribution | |
| MN30-CRSC005 | In distribution | |
| MN30-KH00005 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neurological Stereotaxic Instrument | Medtronic Navigation, Inc. | 844 |
| PMT Corporation – Stereotactic | PMT Corp. | 255 |
| Leksell Stereotactic System | Elekta Instrument AB | 199 |
| Neurological Stereotaxic Instrument | Inomed Medizintechnik Gmbh | 146 |
| Neurological Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 125 |
| CRW® | Integra Lifesciences Corporation | 107 |
| Leksell Stereotactic System | Elekta Solutions AB | 93 |
| microTargeting™ Insertion Tube with Stylet | FHC, Inc. | 60 |
| Leksell Stereotactic System Neurosurgical Instruments | Elekta Instrument AB | 58 |
| Leksell Vantage Stereotactic System | Elekta Instrument AB | 53 |
| Stealth Autoguide™ System | Medtronic Navigation, Inc. | 50 |
| microTargeting™ Insertion Tube | FHC, Inc. | 48 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241333 | 2025-01-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.