FDA.reportPublic FDA data

Panoramic Corporation

Primary DI
00862309000347
Brand
Panoramic Corporation
Company
YOUNG PS ACQUISITION, LLC
Model
PC-4000
Device description
Unit, X-ray, Extraoral with Timer- PC-4000
Published
2017-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043557000MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMSPanoramic Corp.2005-01-13EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862309000347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862309000347008623090003478623090003470862309000347

GMDN Terms#

Term, Definition table
TermDefinition
Stationary extraoral dental x-ray system, digitalA diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed outside the mouth, the purpose being to visualize the entire mouth area showing teeth on both the upper and lower jaws. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119620784
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862309000309Panoramic CorporationPC-10002017-05-24
00862309000316Panoramic CorporationPC-1000/Laser 10002017-05-24
00862309000330Panoramic CorporationPC-30002017-05-24
00862309000354Panoramic CorporationDigital Pnaormic X-Ray Encompass2017-05-24
00862309000361Panoramic CorporationCCD Encompass2017-05-24
00862309000378Panoramic Corporation3D Encompass2017-05-24
00862309000385Panoramic Corporation - Envision P97682040132018-04-20
00862309000392Panoramic Corporation - Envision C197682040142018-04-20

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Primary DI, Brand, Company table
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08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
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