C-beam

Primary DI
00860016243804
Brand
C-beam
Company
Pulmera, Inc.
Model
1.0
Device description
The C-Beam device is intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures. The visualization of such anatomical structures assists the clinician in the clinical outcome.
Published
2026-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252735000C-beamPulmera, Inc.2026-05-22OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860016243804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016243804008600162438048600162438040860016243804

GMDN Terms#

Term, Definition table
TermDefinition
Stationary general-purpose fluoroscopic x-ray system, digitalA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.

Regulatory Flags#

DUNS number
116814767
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
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