FDA.reportPublic FDA data

BATCAM MultiProbe, 230V, Terason 3000

Primary DI
00852656007076
Brand
BATCAM MultiProbe, 230V, Terason 3000
Company
Best Nomos
Model
209718
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
00852656007076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852656007076008526560070768526560070760852656007076

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound patient positioning systemAn assembly of devices used to locate, with ultrasound, internal soft-tissue anatomy that moves relative to external or bony landmarks, to enable subsequent adjustment of the patient for precise external beam radiation treatment of the target tissue. It typically includes an ultrasound imaging system, computerized workstation(s), optical tracking devices, and dedicated software.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
EPTWS070031Q5200VERIQAPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-17
EPTWS0700300PQASoftPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15