Who else makes this device?

Name: Serenys DR
Brand: Serenys DR

Radiology › DiagnosticFull Field Digital, System, X-Ray, Mammographic

Serenys DR

SERENYS DR is a mammography solution composed of equipment and software for different examination types and optimized for digital imaging. SERENYS DR is a digital mammography system also…

Registry build 21.09.26

SERENYS DR is a mammography solution composed of equipment and software for different examination types and optimized for digital imaging. SERENYS DR is a digital mammography system also called full-field digital mammography (FFDM) system. It is an integrated system that includes both the X-ray delivery system and integrated detector. It consists of an x-ray generator, x-ray control, x-ray tube, collimator, beam filter, breast compression system, grid, image receptor system, and accessories. The image receptor system consists of a built-in full-filed solid state detector, acquisition software, acquisition work station (AWS), and accessories. It includes an optional stereotactic biopsy device (BYM 3D DMD) with its respective Operator’s Manual. Helianthus is intended to produce two-dimensional digital mammographic images of the breast for diagnosis of breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code MUE
Manufacturer	City	Province	Registered as	Device types
Fujifilm Imaging System (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Manufacturer	3

Record

Regulatory record for Serenys DR
Listed by	Metaltronica Spa, Italy
FDA product code	MUE
Device type	Full Field Digital, System, X-Ray, Mammographic
Device class	Class 2
Regulation	21 CFR 892.1715
Establishment	Manufacturer
510(k)	K202822
Record published	2026-05-25

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Serenys DR
Catalogue number	Size	Status
SERENYS DR		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Selenia® Dimensions®	Hologic, Inc.	47
Selenia Ffdm	Hologic, Inc.	29
Full Field Digital, System, X-Ray, Mammographic	GE Medical Systems, LLC	10
Senographe Pristina	GE Medical Systems, LLC	10
Directview CR Mammography Cassette with EHR-M Screen	Carestream Health, Inc.	10
Giotto Class	IMS Giotto SPA	6
Directview CR Mammography Cassette with EHR-M3 Screen	Carestream Health, Inc.	5
Giotto Image 3DL	I.M.S. Internazionale Medico Scientifica SRL	5
CR-IR 392	Fujifilm Corporation	3
Giotto Image	IMS Giotto SPA	3
CR HD5.0 AEC Cassette	Agfa Healthcare Inc.	3
Directview CR Mammography Cassette with HR Screen	Carestream Health, Inc.	3

Showing 12 of 103. All products under Full Field Digital, System, X-Ray, Mammographic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K202822	2021-12-15

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P080018	2010-11-03	KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY	Carestream Health, Inc.
P050014	2009-01-09	FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE	Fujifilm Medical System U.S.A., Inc.
P990066	2007-08-01	GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL	GE Healthcare GmbH
P030010	2004-08-20	SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	Siemens Medical Solution
P010017	2004-05-12	SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	Hologic, Inc.
P010025	2003-09-24	SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	Hologic, Inc.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.