QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)

Q: What is the product code of K230221?

The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.

FDA 510(k) K230221 · Versant Medical Physics and Radiation Safety

Substantially Equivalent

510(k) numberK230221

Submission

Device name: QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
Applicant: Versant Medical Physics and Radiation Safety
Kalamazoo, MI, US
Received: January 26, 2023
Decision date: August 28, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IYX – Camera, Scintillation (Gamma)
Device class: Class I (low risk)
Regulation: 21 CFR 892.1100
Specialty: Radiology

Other 510(k)s with product code IYX

510(k)	Device	Applicant	Decision
K212587	3D-RD-SIYX · Traditional	Radiopharmaceutical Imaging and Dosimetry, LLC	02/22/2023SE
K163687	Olinda ExmIYX · Traditional	Hermes Medical Solutions AB	07/19/2017SE
K160933	Discovery NM 750b BopsyIYX · Traditional	GE Healthcare	11/18/2016SE
K162052	Sentinella 102, Sentinella 102 HorusIYX · Special	General Equipment For Medical Imaging (Oncovision-	08/18/2016SE
K143156	Sentinella 102; Sentinella 102 HorusIYX · Traditional	General Equipment For Medical Imaging (Oncovision-	11/18/2014SE
K123408	Ergo Imaging SystemIYX · Traditional	Digirad Corp.	01/15/2013SE
K111791	Lumagem Molecular Breast Imaging SystemIYX · Traditional	Gamma Medica-Ideas Incorporated	09/23/2011SE
K110384	Dilon 6800 Acella (Acella)IYX · Traditional	Dilon Technologies, Inc.	05/03/2011SE
K110601	Sentinella 102IYX · Traditional	General Equipment For Medical Imaging, S.A.	03/18/2011SE
K102231	Discovery NM 750BIYX · Traditional	Ge Medical Systems Israel, Functional Imaging	11/03/2010SE

Questions and answers

When was QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) cleared by the FDA?

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) (K230221) received a 510(k) decision of Substantially Equivalent on August 28, 2023, 214 days after the submission was received.

What is the product code of K230221?

The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.