FDA.reportPublic FDA data

BATCAM MultiProbe, 115V, Terason 3000

Primary DI
00852656007021
Brand
BATCAM MultiProbe, 115V, Terason 3000
Company
Best Nomos
Model
209678
Device description
Parts of the internal anatomy move relative to external or bony landmarks. The BATCAM 7.0 MultiProbe Ultrasound Localization and Positioning System resolves this movement by permitting it’s users to locate and position the part of the internal anatomy that is being treated as accurately and correctly as possible for the delivery of conformal radiation without relying on external structures.
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
IYEAccelerator, Linear, Medical
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070611000BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6Nomos Corp.2007-07-11IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852656007021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852656007021008526560070218526560070210852656007021

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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