FDA.report

DRYVIEW 5950 Laser Imaging System

Primary DI
60889976571002
Brand
DRYVIEW 5950 Laser Imaging System
Company
CARESTREAM HEALTH, INC.
Model
DRYVIEW 5950 Laser Imaging System
Catalog number
6571004
Device description
Dryview 5950 Laser Imager/M/120V
Published
2017-08-02
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

Related Records

Product Codes

CodeName
LMCCamera, multi format, radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LMCCamera, Multi Format, RadiologicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
60889976571002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
6088997657100260889976571002

GMDN Terms

TermDefinition
Diagnostic-imaging multiformat cameraA mains electricity (AC-powered) camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.

Sterilization Methods

Method

Regulatory Flags

DUNS number
793169512
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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