CapsoCloud

Primary DI
00860016605909
Brand
CapsoCloud
Company
CAPSOVISION, INC.
Model
3
Catalog number
CLD
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QZFGastrointestinal Capsule Endoscopy Analysis Software Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZFGastrointestinal Capsule Endoscopy Analysis Software DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254230000CapsoView (CVV); CapsoCloud (CLD)CapsoVision, Inc.2026-09-25QZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860016605909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016605909008600166059098600166059090860016605909

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopy support softwareA software program intended to display, analyse/process, and possibly acquire images of the gastrointestinal tract acquired by an endoscopic device (endoscope or capsule) to assist with the visual examination and treatment of a condition (e.g., polyp detection). It may be capable of differentiating lesions and/or producing a probability score (e.g., neoplastic versus non-neoplastic), and/or adjusting capsule settings [e.g., position in the gastrointestinal (GI) tract]. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
408-624-1488info@capsovision.com

Regulatory Flags#

DUNS number
789635740
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867770000292CapsoView4CVV2026-10-20
00867770000223CapsoCloud2CLD2020-03-02
00867770000216CapsoView327592018-07-17
00867770000278CE Deliver DLV2026-01-08
00867770000285CE Deliver DLV2026-01-08
00867770000261CapsoCam PlusSV-3KIT27952020-12-11
00867770000254CapsoRetrieveCVR112092020-09-28
00867770000209CapsoCam PlusSV-327952018-07-17
00867770000230CapsoAccess326682018-07-17
00867770000247CapsoRetrieveCVR112192018-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00867770000292CapsoViewCAPSOVISION, INC.QZF2026-10-20
00810164590275NaviCam ProScan AI SoftwareANX ROBOTICA CORPQZF2026-02-16