FDA.reportPublic FDA data

Compass International

Primary DI
B169TP300
Brand
Compass International
Company
Compass International
Model
TP-30
Catalog number
TP-30
Device description
Cygnus Test Phantom
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B169TP300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality diagnostic imaging phantom, test objectA device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations and is a quality assurance device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic imaging systems. A multi-modality phantom is specifically intended for use with more than one diagnostic imaging modality, e.g., magnetic resonance imaging (MRI), ultrasound, x-ray and nuclear medicine (NM) systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809466410
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B169CYGERG10D0Compass InternationalCYG-ERG-10DCYG-ERG-10D2016-08-12
00860009258129COMPASS CT Adaptation Stereotactic SystemPION-20CT-NBAR-102026-03-18
00860009258136COMPASS Stereotactic Retractor SystemPION-20RE-202026-03-18
00860009258105COMPASS CYGNUS-PFS IGS SystemCYG-PFSN-10TPCYG-PFSN-10TP2026-01-29
00860009258112COMPASS Stereotactic SystemPION-20PION-202026-01-29
B169RU1500Compass InternationalRU-150RU-1502016-08-26
B169RU3000Compass InternationalRU-300RU-3002016-08-26
B169CYG10B2TP0Compass InternationalCYG-10-B2TPCYG-10-B2TP2016-09-13
B169CYG10BTP0Compass InternationalCYG-10-BTPCYG-10-BTP2016-09-13
B169CYG10LPTP0Compass InternationalCYG-10-LPTPCYG-10-LPTP2016-09-13
B169CYG10LSTP0Compass InternationalCYG-10-LSTPCYG-10-LSTP2016-09-13
B169CYG10PTP0Compass InternationalCYG-10-PTPCYG-10-PTP2016-09-13
B169CYG10STP0Compass InternationalCYG-10-STPCYG-10-STP2016-09-13
B169CYG14FSCT100Compass InternationalCYG-14F-SCT10CYG-14F-SCT102016-09-13
B169CYG4FCT100Compass InternationalCYG-4F-CT10CYG-4F-CT102016-08-12
B169CYG4FCT10TP0Compass InternationalCYG-4F-CT10TPCYG-4F-CT10TP2016-09-13
B169CYG5FNPT100Compass InternationalCYG-5F-NPT10CYG-5F-NPT102016-09-13
B169CYG5FNPT10TP0Compass InternationalCYG-5F-NPT10TPCYG-5F-NPT10TP2016-09-13
B169CYG9FSCT100Compass InternationalCYG-9F-SCT10CYG-9F-SCT102016-09-13
B169CYG9FSCT10TP0Compass InternationalCYG-9F-SCT10TPCYG-9F-SCT10TP2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
06974813832681NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832698NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832704NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832711NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832728NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832735NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832742NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832759NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832766NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832773NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832780NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832797NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832810NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832827NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832834NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832841NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
00199150071968Stealth AXiS Leica KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071975Stealth AXiS Kinevo 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071982Stealth AXiS Pentero 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00850088866001CBYONMED-SURGICAL SERVICES, INC.HAW2026-09-25
00199150054404ZEISS TIVATO 700MEDTRONIC NAVIGATION, INC.HAW2026-09-21
00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503713Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503720Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18