FDA.reportPublic FDA data

APELEM

Primary DI
03760172650430
Brand
APELEM
Company
APELEM
Model
Persona RF PREMIUM
Device description
Remote controlled radiology system
Published
2022-04-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K203010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203010000Platinum dRF Imaging SystemApelem-Dms Group2021-01-22JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760172650430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760172650430037601726504303760172650430

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system table, poweredA powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.

Regulatory Flags#

DUNS number
268596533
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
03760172650065APELEMDRX-Excel Plus2016-05-23
03760172650409APELEMFDX Visionary RF PREMIUM2023-06-07
03760172650003APELEMPLATINUM dRF2016-05-23
03760172650447APELEMPLATINUM dRF (8L)2023-06-07
03760172650485APELEMPersona RF PREMIUM (8L)2023-06-07
03760172650508APELEMDRX Excel Plus (8L)2023-06-07

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Primary DI, Brand, Company table
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B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
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