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CINA-CSpine 1.0

by Avicenna.ai

CINA-CSpine 1.0 is a medical device (FDA Class II; FDA product code QAS, Radiological Computer-Assisted Triage And Notification Software) made by Avicenna.ai, cleared under FDA 510(k) K240942 on 12 Sep 2024, registered in EUDAMED and listed in FDA GUDID since 7 Oct 2024 (UDI-DI B826CINACSPINE100), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240942

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberB826CINACSPINE100 UDI-DI Date7 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK240942 Date12 Sep 2024IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K240942 decided 12 Sep 2024 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI B826CINACSPINE100 listed 7 Oct 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240942
  2. Listed FDA GUDID B826CINACSPINE100

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
CINA-CSpine
Generic name
Radiology DICOM image processing application software
Model / reference
1.0
Primary DI / UDI-DI
B826CINACSPINE100
510(k) Number
FDA product code
QAS
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology DICOM image processing application software

Similar devices in this category

Other devices filed under Radiology DICOM image processing application software.

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See all devices from Avicenna.ai →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)