FDA.reportPublic FDA data

Sonalis

Primary DI
00852656007014
Brand
Sonalis
Company
Best Nomos
Model
209876
Device description
The Sonalis Ultrasound System is a real time, two dimensional, diagnostic ultrasound system which produces high quality images through user friendly operation. The system currently supports imaging applications for trans-rectal ultrasound imaging.
Published
2016-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100204000SONALISSmith Associates2010-02-19ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852656007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852656007014008526560070148526560070140852656007014

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(412) 312-6700info@nomos.com

Regulatory Flags#

DUNS number
146920025
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852656007229Disposable Template, 18 Gauge, Non-Siemens, 5 Pack60462016-10-31
00852656007236Disposable Template, 18 Gauge, Siemens, 5 Pack60472016-10-31
00852656007243Disposable Template, 17 Gauge, Non-Siemens, 5 Pack60482016-10-31
00852656007250Disposable Template, 17 Gauge, Siemens, 5 Pack60492016-10-31
00852656007335Disposable Template, 18 Gauge, Non-Siemens, Single61042016-10-31
00852656007342Disposable Template, 18 Gauge, Siemens, Single61052016-10-31
00852656007359Disposable Template, 17 Gauge, Non-Siemens, Single61062016-10-31
00852656007366Disposable Template, 17 Gauge, Siemens, Single61072016-10-31
00852656007519Cradle, SonoScape2107812022-11-17
00852656007175Reusable Frame, Best Precision Stepper60502016-10-31
00852656007182Reusable Frame, Bard SurePoint Stepper60512016-10-31
00852656007199Reusable Frame, Civco/BW Stepper (Non-Siemens Grid)60522016-10-31
00852656007205Reusable Frame, Civco/BW Stepper (Siemens Grid)60532016-10-31
00852656007212Reusable Frame, CMS AccuSeed60622016-10-31
00852656007267High Dose Rate Frame, Best Precision Stepper (Siemens Grid)60122016-10-31
00852656007274High Dose Rate Frame, Best Precision Stepper (BK Grid)60362016-10-31
00852656007281High Dose Rate Frame, Civco/BW Stepper60632016-10-31
00852656007298High Dose Rate Frame, Tayman Stepper60642016-10-31
00852656007304High Dose Rate Frame, SurePoint Stepper60652016-10-31
00852656007311High Dose Rate Sandwich, 15 Gauge60132016-10-31

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