FDA.reportPublic FDA data

NA

Primary DI
06974813830045
Brand
NA
Company
Sinovation (Beijing) Medical Technology Co., Ltd
Model
37110003
Device description
Optical 3D scanner
Published
2023-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220072000Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd.2023-06-18HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974813830045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974813830045069748138300456974813830045

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560671783
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974813832681NAGUD-CR-G2026-09-29
06974813832698NAGUD-DBS-AO2026-09-29
06974813832704NAGUD-DBS-LP2026-09-29
06974813832711NATT-2.2-302026-09-29
06974813832728NATT-2.2-702026-09-29
06974813832735NATT-2.5-702026-09-29
06974813832742NATT-5.0-652026-09-29
06974813832759NATT-50-30D2026-09-29
06974813832766NATT-50-40D2026-09-29
06974813832773NATT-50-50D2026-09-29
06974813832780NATT-50-35D2026-09-29
06974813832797NAPRB-CR-S2026-09-29
06974813832810NATT-50-45D2026-09-29
06974813832827NAGD-122026-09-29
06974813832834NASDA-A21-32026-09-29
06974813832841NASDA-A30-12026-09-29
06974813830069NA371000032023-08-31
06974813830076NA371000052023-08-31
06974813830083NA371000132023-08-31
06974813830113NA371000162023-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088866018CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866025CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866032CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866049CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866056CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866063CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866070CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866087CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866094CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866100CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866117CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866124CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866131CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866148CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866155CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866162CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866179CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866186CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866193CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866209CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866216CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866223CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866230CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866247CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866254CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866261CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866278CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866285CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866292CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866308CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29