FDA.reportPublic FDA data

Encompass™

Primary DI
00841962119719
Brand
Encompass™
Company
Qfix
Model
RT-4600-20
Catalog number
RT-4600-20
Device description
SRS Cushion Support
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
JAICouch, Radiation Therapy, Powered
JAKSystem, X-Ray, Tomography, Computed
KPSSystem, Tomography, Computed, Emission
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LNHSystem, Nuclear Magnetic Resonance Imaging
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
JAICouch, Radiation Therapy, PoweredRadiology2
JAKSystem, X-Ray, Tomography, ComputedRadiology2
KPSSystem, Tomography, Computed, EmissionRadiology2
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152321000kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm openingQfix2015-12-04IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841962119719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841962119719008419621197198419621197190841962119719

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., helmet, frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine typically during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-842-8688regulatory@cqmedical.com

Regulatory Flags#

DUNS number
808875397
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841962120500Single Hand Extremity FibreplastRT-E778KPR2HRT-E778KPR2H2026-06-05
00841962120517Knee / Elbow Extremity FibreplastRT-E778KPR2NERT-E778KPR2NE2026-06-05
00841962120524Foot Extremity FibreplastRT-E778KPR3FTRT-E778KPR3FT2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastRT-E778KPR3HSRT-E778KPR3HS2026-06-05
00841439115305MultiFix 2RT-54112026-06-04
00841439115312MultiFix 2 - JointGlowRT-54122026-06-04
00841439115329Extremity RiserRT-54132026-06-04
00841439115336Extremity Riser - JointGlowRT-54142026-06-04
00841439115343MultiFix Indexing PostRT-54152026-06-04
00841439115237Opti-TattUTRT-4100UTRT-41002026-05-29
00841439115244Opti-TattUTRT-4200UTRT-42002026-05-29
00841439115251Opti-TattUTRT-4300UTRT-43002026-05-29
00841962120562FibreplastRT-A182KYSDNRT-A182KYSDN2026-05-26
00841962120425Opti Handle Thermoplastic AdapterRT-4546-05RT-4546-052026-05-18
00841962120319Aquaplast PS™PS-1309CSSPS-1309CSS2025-07-09
10841962107447Aquaplast PS™PS-1307PS-13072016-09-13
10841962108307VacQfix™RT-4517-4079VF15RT-4517-4079VF152016-09-13
10841962109090QUANTUM™ CT OverlayRT-4550TE24RT-4550TE242016-09-13
10841962109274kVue™ EdgeRT-4551KVERT-4551KVE2016-09-13
10841962109403Stradivarius™RT-4558CB01RT-4558CB012016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
00856100006493Respiratory Gating for ScannersVARIAN MEDICAL SYSTEMS, INC.JAK2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
10884521785977superDimensionCovidien LPJAK2026-05-29