Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010701021

FEI Number

3010701021

Entity Name

MACROMEDICS BV

City/State/Country

Moordrecht Zuid-Holland, NL

Establishment Address

Oostbaan 670, Moordrecht Zuid-Holland 2841ML, NL

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

MacroMedics BV (Owner Number: 10046168)

Owner / Operator Contact Address

Oostbaan 670, Moordrecht, NL-ZH 2841ML, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212909

PMA Number

N/A

All Registered Proprietary Names

Mask DSPS®-PROS, set/5 DSPS-Prominent® Cradle-II DSPS-Prominent® baseplate, MR DSPS-Prominent® baseplate DSPS-Prominent® Cradle-VI DSPS PRO Mask Shim Set HNS Mask DSPS®-PROSCL set/5 DSPS PRO Mask Shim Set HO DSPS-Prominent® Cradle-IV Mask DSPS®-PROSH set/5 DSPS-Prominent® SH profile set/2 Mask DSPS®-PROSVR, set/5 Handgrips HNS, set/2 DSPS®-PRO Coil Ref Tool Mask DSPS®-PROSHL set/5 Mask DSPS®-PROSCVRL set/5 DSPS-Prominent® Cradle-III Mask DSPS®-PROSC set/5 Mask DSPS®-PROH, set/5 DSPS-Prominent® Cradle-I Mask DSPS®-PRO, set/5 DSPS-Prominent® Cradle-VII Mask DSPS®-PROSHVRL set/5 Mask DSPS®-PROSL, set/5 Mask DSPS®-PROSCVR set/5 Mask DSPS®-PROSVRL, set/5 Mask DSPS®-PROSHVR set/5 BreastBoard SX FlexBoard EagleBoard CouchStripCS53FGF-PRO CouchStrips VacuumCushions LEPS FeetSupports

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-03-27
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2025-03-27
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2022-12-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-12-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-12-22
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2023-12-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-12-14
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2022-12-14

Official Correspondent

J. Drenth

US Agent Details

David Holdford Email: dholdford@innovativeoncology.com Phone: (800) 9930928

Related Public Records

Same Entity

MacroMedics BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

Similar Registrations

Registration Number	Establishment Name	Location
3019844073	TracInnovations A/S	Ballerup Hovedstaden, DK
3012169560	SIARON MEDICAL LTD	Vancouver British Columbia, CA
3033536331	NEOSCAN SOLUTIONS GMBH	Magdeburg Saxony-Anhalt, DE
3020162557	SPINTECH, INC.	Bingham Farms, MI, US
3012354318	JIANGSU MAGSPIN INSTRUMENT CO., LTD	Kunshan Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010701021. Last updated year: 2026. Please use registration number 3010701021 when referencing this establishment in official correspondence.