FDA.reportPublic FDA data

Planmed

Primary DI
06430035430055
Brand
Planmed
Company
Planmed Oy
Model
Sophie Classic
Device description
Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of breast cancer.
Published
2016-09-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZHSystem, X-Ray, Mammographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZHSystem, X-Ray, MammographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013656000PLANMED SOPHIE & PLANMED SOPHIE CLASSICPlanmed OY2002-01-16IZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035430055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035430055064300354300556430035430055

GMDN Terms#

Term, Definition table
TermDefinition
Stationary mammographic x-ray system, analogueAn assembly of devices specifically designed to provide a fixed installation (in an imaging facility, or transportation van) x-ray system to compress and image the breast. It is primarily used to optimize the capability of users to visually evaluate x-ray film images representing the anatomy and function of blood and lymphatic vessels within the human breast. It uses analogue or analogue-to-digital conversion techniques for image capture and display. It is used for breast cancer screening and in conjunction with the placement of biopsy markers and stereotactic biopsy and lesion localization equipment requiring x-ray guidance.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
459718193
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035430130PlanmedXFI2025-11-21
06430035430024PlanmedNuance Excel2016-09-08
06430035430062Planmed Verity2016-09-07
06430035430079PlanmedClarity2018-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045518247Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518261Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518278Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518285Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518292Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518087Affirm®Hologic, Inc.IZH2025-07-17
08056977360113SMART FINDER IMS GIOTTO SPAIZH2023-06-25
15420045512931AFFIRM™ SPECIMEN IMAGINGHologic, Inc.IZH2021-07-10
15420045512948AFFIRM™ CONTRAST BIOPSYHologic, Inc.IZH2020-11-18
00813079020400Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
00813079020417Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
00813079020424Open Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
10813079020407Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
20813079020411Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
10813079020421Open Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
B852SPECBOARD2220SPECBOARD JRMACBRUD CORPORATIONIZH2020-03-18
B852SPECBOARD4440SpecboardMACBRUD CORPORATIONIZH2020-03-18
15420045510845Affirm Prone Biopsy SystemHologic, Inc.IZH2019-09-19
15420045510852Affirm Prone Biopsy SystemHologic, Inc.IZH2019-09-19
15420045510869Affirm Prone Biopsy SystemHologic, Inc.IZH2019-09-19
25420045507347MammoPad Radiolucent CushionHologic, Inc.IZH2018-02-14
15420045507173Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-12-01
15420045507180Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-11-21
15420045507197Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-11-21
25420045507330MammoPad Radiolucent CushionHologic, Inc.IZH2017-07-26
15420045506503Affirm Prone Biopsy SystemHologic, Inc.IZH2017-04-26
15420045506510Affirm Prone Biopsy SystemHologic, Inc.IZH2017-04-26
15420045506534Affirm Prone Biopsy SystemHologic, Inc.IZH2017-04-26
15420045505926Multicare PlatinumHologic, Inc.IZH2017-03-30
15420045506077Digital Spot Mammography System, DSMHologic, Inc.IZH2017-03-30