FDA.reportPublic FDA data

OPERA SWING

Primary DI
08054890480031
Brand
OPERA SWING
Company
GENERAL MEDICAL MERATE SPA
Model
STRETCHER
Device description
The device is a stretcher in carbon fiber and it is raised via an hydraulic piston mechanism which is controlled by a foot-pedal.
Published
2016-09-22
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
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140380000OPERA SWINGGeneral Medical Merate S.P.A2014-09-26JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054890480031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054890480031080548904800318054890480031

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic stretcherA manually-operated device consisting of a radiation translucent platform mounted on a wheeled frame designed to transport and support a recumbent patient during the acquisition of radiographic images. It may include various accessories (e.g., slots and cassette-support attachments). It is commonly used in emergencies to produce the first diagnostic images of a patient when there is little time for conventional protocol (e.g., in cases of serious patient trauma or during a large-scale catastrophe).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length210Centimeter
Width65Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428658934
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054890480048OPERA SWINGOPERA D4000RF2016-09-22
08054890480055CLISIS SYSTEMSCLISIS SYSTEMS2018-07-11
08054890480079CLISIS SYSTEMSOPERA D4000RF2018-07-11
08054890480109Discovery RF180Discovery RF1802018-07-11
08054890480123Discovery RF180OPERA D4000RF2018-07-11
08054890480161Discovery RF180WST-SX2019-04-12
08054890480178Discovery RF180WS-DX2019-04-12
08054890480185Discovery RF180WS-SX2019-04-12
08054890480024Discovery RF180KALOS2018-07-11
08054890480062CLISIS SYSTEMSCLISIS EXEL DRF2018-07-11
08054890480086CLISIS SYSTEMSWS2018-07-11
08054890480093CLISIS SYSTEMSKALOS2018-07-11
08054890480116Discovery RF180CLISIS EXEL DRF2018-07-11
08054890480130Discovery RF180WST-DX2018-07-11
08054890480147THALESPixium 2430EZ2019-02-10
08054890480154THALESPixium 3543EZ2019-02-10
08054890480000OPERA SWINGX-RAY R&F REMOTE SYSTEM OPERA SWING2016-09-22
08054890480017OPERA SWINGX-RAY REMOTE TABLE OPERA SWING2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
00198953052488AlliaGE MEDICAL SYSTEMSJAA2025-12-17
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHJAA2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHJAA2025-07-30
08800018422601EXTRON 3DRTECH CorporationJAA2025-06-17
08809244060090GenorayGENORAY CO., LTD.JAA2025-05-02
00643169618121O-armMEDTRONIC NAVIGATION, INC.JAA2024-10-10
00195451000799Shockwave IVL System with the Shockwave Javelin Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-10-09
00190376601182IntraOp Alignment SystemALPHATEC SPINE, INC.JAA2024-10-01
00193982184506EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00193982184537EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00195451000539Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000546Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000553Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000560Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000577Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000584Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195278719720AlliaGE MEDICAL SYSTEMSJAA2023-12-08
08800018420805EXTRON 5DRTECH CorporationJAA2023-08-24
08800018420904EXTRON 7DRTECH CorporationJAA2023-08-24
00195451000386Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195451000393Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195451000409Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24