HEFEI MEYER OPTOELECTRONIC TECHNOLOGY INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3013510497	3013510497	HEFEI MEYER OPTOELECTRONIC TECHNOLOGY INC.	1	N	2026-01-01	No.668 Wangjiang West Road, High and New Tech, Industry Developm Hefei Anhui CN 230088

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
325337	1520201466	K261748	Dental Cone-beam Computed Tomography (mDX-15P Series)	OAS	2026-07-23
325337	1613002601

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OAS	1	2026-07-23

GUDID#

Meyer - The equipment is an advanced digital X-ray imaging unit that producing high quality digital images of dentition, TMJ and skull. The equipment uses cone beam computed tomography (CBCT) to produces three-dimensional (3D) radiographic images of the maxillofacial, TMJ and ENT anatomies. The equipment can also produce two-dimensional (2D) panoramic (PANO) images with the tomosynthesis method as well as optional cephalometric (CEPH) images and carpus images with conventional 2D radiography.
Hefei Meyer Optoelectronic Technology Inc.
2026-09-30
Meyer - The equipment is an advanced digital X-ray imaging unit that producing high quality digital images of dentition, TMJ and skull. The equipment uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) radiographic images of the maxillofacial, TMJ and ENT anatomies. The equipment can also produce two-dimensional (2D) panoramic (PANO) images with the tomosynthesis method as well as optional cephalometric (CEPH) images and carpus images with conventional 2D radiography.
Hefei Meyer Optoelectronic Technology Inc.
2026-09-30
Meyer - The equipment is an advanced digital X-ray imaging unit that producing high quality digital images of dentition, TMJ and skull. The equipment uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) radiographic images of the maxillofacial, TMJ and ENT anatomies. The equipment can also produce two-dimensional (2D) panoramic (PANO) images with the tomosynthesis method as well as optional cephalometric (CEPH) images and carpus images with conventional 2D radiography.
Hefei Meyer Optoelectronic Technology Inc.
2026-09-30
Meyer - The equipment is an advanced digital X-ray imaging unit that producing high quality digital images of dentition, TMJ and skull. The equipment uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) radiographic images of the maxillofacial, TMJ and ENT anatomies. The equipment can also produce two-dimensional (2D) panoramic (PANO) images with the tomosynthesis method as well as optional cephalometric (CEPH) images and carpus images with conventional 2D radiography.
Hefei Meyer Optoelectronic Technology Inc.
2026-09-30