FDA.reportPublic FDA data

Midmark Progeny Vantage Digital Panoramic System with Cephalometric Sensor

Primary DI
00841709102592
Brand
Midmark Progeny Vantage Digital Panoramic System with Cephalometric Sensor
Company
MIDMARK CORPORATION
Model
60-A2009
Catalog number
60-A2009
Device description
Panoramic X-ray PRIMARY COLLIMATOR Assembly
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122643000VANTAGE MODEL V5000, V5100, V5000C, V5100CMidmark Corp.2013-01-07MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709102592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709102592008417091025928417091025920841709102592

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray system collimatorA beam restriction device used in dental x-ray systems to determine the dimension and direction of the x-ray beam, limiting the effects of scattered radiation. It is used to control the size and shape of the x-ray beam reaching the patient's oral cavity and the film or image receptor. It includes all kinds of x-ray beam restriction devices used in diagnostic dental x-ray systems, such as cones and slit collimators. The device is typically designed for use with a specific dental x-ray system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709105791MidmarkIQvitals Zone, w/Nellcor SPO21-200-03202021-05-17
00841709105784MidmarkIQvitals Zone1-200-03102017-04-07
00841709105807MidmarkIQvitals Zone w/Masimo SPO21-200-03302017-04-07
00841709105814MidmarkIQvitals Zone, w/Wireless1-200-03402017-04-07
00841709105821MidmarkIQvitals Zone, w/Nellcor SPO2 and Wirless1-200-03502017-04-07
00841709105838MidmarkIQvitals Zone, w/Masimo SPO2 and Wireless1-200-03602017-04-07
00841709105869MidmarkIQvitals Zone, Non-Wireless4-000-06202017-04-07
00841709105876MidmarkIQvitals Zone, Non-Wireless with Nellcor SPO24-000-06222017-04-07
00841709105883MidmarkIQvitals Zone, Non-Wireless with Masimo SPO24-000-06242017-04-07
00841709105890MidmarkIQvitals Zone, Wireless without SPO24-000-07202017-04-07
00841709105906MidmarkIQvitals Zone, Wireless with Nellcor SPO24-000-07222017-04-07
00841709105913MidmarkIQvitals Zone, Wireless with Masimo SPO24-000-07242017-04-07
00841709107948MidmarkG3G32019-02-08
00841709107979MidmarkG5G52019-02-08
00841709107993MidmarkG6G62019-02-08
00841709108006MidmarkG7G72019-02-08
00841709108020MidmarkG14G142019-02-08
00841709108037MidmarkG10G102019-02-08
00841709108099MidmarkP21/CV3P21/CV32019-02-08
00841709108112MidmarkP21P212019-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01