FDA.reportPublic FDA data

Pan and Ceph system with one sensor, export

Primary DI
00841709102837
Brand
Pan and Ceph system with one sensor, export
Company
MIDMARK CORPORATION
Model
V5150C
Catalog number
V5150C
Device description
Pan and Ceph system with one sensor, export
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUHSystem,X-Ray,Extraoral Source,Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709102837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709102837008417091028378417091028370841709102837

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic dental x-ray system, digitalA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-35 Degrees Celsius66 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-634-6275imagingtechsupport@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709121920MidmarkLT-1400-096LT-1400-0962026-03-19
00841709122088MidmarkLT-1600-108LT-1600-1082026-03-19
00841709122217Midmark029-11924-02LT-15002026-03-19
00841709122132Midmark153839-013153839-0132026-03-11
00841709122149Midmark153720-011153720-0112026-03-11
00841709122156Midmark153740-012153740-0122026-03-11
00841709122163Midmark153740-013153740-0132026-03-11
00841709122170Midmark153740-014153740-0142026-03-11
00841709121913MidmarkLT-1300-001LT-1300-0012026-03-10
00841709121937MidmarkLT-1400-102LT-1400-1022026-03-10
00841709121944MidmarkLT-1400-108LT-1400-1082026-03-10
00841709121951MidmarkLT-1400-114LT-1400-1142026-03-10
00841709121968MidmarkLT-1400-120LT-1400-1202026-03-10
00841709121975MidmarkLT-1400-126LT-1400-1262026-03-10
00841709121982MidmarkLT-1400-132LT-1400-1322026-03-10
00841709121999MidmarkLT-1500-096LT-1500-0962026-03-10
00841709122002MidmarkLT-1500-102LT-1500-1022026-03-10
00841709122019MidmarkLT-1500-108LT-1500-1082026-03-10
00841709122026MidmarkLT-1500-114LT-1500-1142026-03-10
00841709122033MidmarkLT-1500-120LT-1500-1202026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D804W1203005DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203005FLDRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203010DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203015DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203015FLDRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203020DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
08033837934981myrayCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837935001myrayCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936091NewTomCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936176CastelliniCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936411CastelliniCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
06970569090856Digital Intraoral X-ray Imaging SystemiRay GroupMUH2025-08-29
06970569090863Digital Intraoral X-ray Imaging SystemiRay GroupMUH2025-08-29
D178XR3800Flight Dental SystemsFlight Dental Systems USA Inc.MUH2025-08-29
08800003027088RAYSCAN α-PRay Co., LtdMUH2025-08-25
03760262650814Owandy RadiologyOWANDY RADIOLOGYMUH2025-05-15
D804W13000050U-SENSE HDDE GÖTZEN SRLMUH2025-05-15
08809244060199GenorayGENORAY CO., LTD.MUH2025-05-02
08809244060229GenorayGENORAY CO., LTD.MUH2025-05-02
08809244060236GenorayGENORAY CO., LTD.MUH2025-05-02
00304040190623Henry ScheinHENRY SCHEIN, INC.MUH2025-03-05
06941877815196EighteethChangzhou Sifary Medical Technology Co., Ltd.MUH2025-01-21
08033837936817myrayCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08033837936848NewTomCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08033837936855CastelliniCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08800016401950VistaPano S 2.0VATECH CO., LTD.MUH2024-12-13
08800016401967VistaPano S Ceph 2.0VATECH CO., LTD.MUH2024-12-13
D9021050013MISTER X RAYDental Savings Club IncMUH2024-12-12
03760262651606I-MAXOWANDY RADIOLOGYMUH2024-11-11
D804W1200001FL0X-MIND primeDE GÖTZEN SRLMUH2024-11-11