FDA.reportPublic FDA data

SIR-Spheres® Microspheres Activity Calculator (SMAC)

Primary DI
00850014612108
Brand
SIR-Spheres® Microspheres Activity Calculator (SMAC)
Company
Sirtex Medical Inc.
Model
X-SMAC-01
Device description
Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
Published
2021-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPSSystem, Tomography, Computed, Emission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202392000SIR-Spheres Microspheres Activity Calculator (SMAC)Sirtex Medical US Holdings, Inc.2020-10-23KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014612108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014612108008500146121088500146121080850014612108

GMDN Terms#

Term, Definition table
TermDefinition
Clinical management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.

Contacts#

Phone, Email table
PhoneEmail
1-888-474-7839info-us@sirtex.com

Regulatory Flags#

DUNS number
127504939
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055697003LAVA-18, 2 mLSLLES1822023-10-23
00850055697010LAVA-34, 2 mLSLLES3422023-10-23
00850055697027LAVA-18, 6 mLSLLES1862023-10-23
00850055697034LAVA-34, 6 mLSLLES3462023-10-23
00850055697041LAVA Mixing Kit, 2 mLSLLESMK22023-10-23
00850055697058LAVA Mixing Kit, 6 mLSLLESMK62023-10-23
00850014612153SIR-Spheres Y-90 resin microspheresSIR-Y0032026-05-28
00850014612030SIR-Spheres Y-90 resin microspheresSIR-Y0012024-07-15
00850014612146SIR-Spheres Y-90 resin microspheresSIR-Y0022024-03-28
00850014612061SIR-Spheres V-VialSIR-V0012021-07-15
00850014612047SIR-Spheres Delivery ApparatusSIR-B0012021-07-14
00850014612054SIR-Spheres Delivery SetSIR-D0012021-07-14
00850014612078SIR-Spheres V-Vial HolderSIR-H0012021-07-14
00850014612092SIR-Spheres Accessories PackSIR-K0022021-07-14
00850014612085SIR-Spheres Syringe ShieldSIR-S0012021-07-09
00850014612009SIROS Delivery DomeSIR-10100SIR-101002021-01-05
00850014612016SIROS D-Vial Prep SetSIR-10200SIR-102002021-01-05
00850014612023SIROS Delivery SetSIR-10300SIR-103002021-01-05
M425SIRY0010SIR-Spheres microspheresSIR-Y0012014-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120548Alpine Stirrups, Metric, LeftQfixKPS2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixKPS2026-04-14
00859873006240HermiaHermes Medical Solutions ABKPS2026-03-05
B133NEUROQ412601160NeuroQSYNTERMED INCORPORATEDKPS2026-03-04
B133ECTB422512090Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-02-26
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04068151020472BIOGRAPH OneSiemens Healthineers AGKPS2026-01-20
00841962120456Alta for HexaPODQfixKPS2026-01-14
04068151048070Biograph Trinion.X EP9 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2026-01-09
00841962120388Lumen AirShuttleQfixKPS2025-12-02
00841962120395Symphony Locating Bar, PH StyleQfixKPS2025-12-02
10841962119457Symphony Locating Bar, Prodigy2™QfixKPS2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixKPS2025-10-23
08809873532005BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532012BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532029BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532036BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532043BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532050BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
00841439114841ZiFix TraverseMEDTEC, INC.KPS2025-09-12
00841962120340Edge Guide SystemQfixKPS2025-09-11
00198953061329NMCT 860G E MEDICAL SYSTEMS ISRAEL LTD.KPS2025-09-09
00198953061336NMCT 850G E MEDICAL SYSTEMS ISRAEL LTD.KPS2025-09-09
04068151048063Biograph Trinion.X EP9 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2025-08-28
B133NEUROQ412507140NeuroQSYNTERMED INCORPORATEDKPS2025-08-06
06971576832033uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832163uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832231uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832255uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
B133ECTB4225063000Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-08-01