FDA.reportPublic FDA data

Discovery RF180

Primary DI
08054890480116
Brand
Discovery RF180
Company
GENERAL MEDICAL MERATE SPA
Model
CLISIS EXEL DRF
Device description
It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting table or it is possible to perform examination with detector directly in contact with the patient by using in combination the optional: Overhead Tube Suspension, Wall Stand and 2nd Wi-Fi detector.
Published
2018-07-11
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
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXJTable, RadiologicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173395000
K213081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173395000MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A2018-05-21JAA
K213081000CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A2021-10-26IZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054890480116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054890480116080548904801168054890480116

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopy/angiography table, poweredA powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).

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
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
08054890480031OPERA SWINGSTRETCHER2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953081839NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953081877NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953089835NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00198953089842NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00887761943209PadsBaxter Medical Systems GmbH + Co. KGKXJ2025-01-20
00887761966673Carbon Pelvic systemBaxter Medical Systems GmbH + Co. KGKXJ2025-01-17
00857534006691ORT400 TableIMRIS Imaging, Inc.KXJ2024-10-04
00857534006738ORT200IMRIS Imaging, Inc.KXJ2024-10-04
00887761967977Hillrom™Baxter Medical Systems GmbH + Co. KGKXJ2024-02-22
00887761967984Hillrom™Baxter Medical Systems GmbH + Co. KGKXJ2024-02-22
00810050245487NADOMICO MED-DEVICE, LLCKXJ2023-05-01
00810050245463NADOMICO MED-DEVICE, LLCKXJ2023-01-13
00887761968424TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761969414PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761967632X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967649X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967656X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967717Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967724Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967731Back SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967786Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967885PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967915PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967939PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03