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CINA-iPE 1.0

by Avicenna.ai

CINA-iPE 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) K233968 on 13 Mar 2024, registered in EUDAMED and listed in FDA GUDID since 29 Mar 2024 (UDI-DI B826CINAIPE100), active as of 23 Oct 2026.

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

CE MDR CE MDD 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) K233968

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 NumberB826CINAIPE100 UDI-DI Date29 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK233968 Date13 Mar 2024IssuedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K233968 decided 13 Mar 2024 Active
  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI B826CINAIPE100 listed 29 Mar 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233968
  2. Listed FDA GUDID B826CINAIPE100

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CINA-iPE
Generic name
Radiology DICOM image processing application software
Model / reference
1.0
Primary DI / UDI-DI
B826CINAIPE100
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

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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)