1
/
of
0
FDA 510(k), K182643, IRIS 1.0 System
FDA 510(k), K182643, IRIS 1.0 System
Regular price
$89.00 USD
Regular price
Sale price
$89.00 USD
Unit price
/
per
510(K) Number: K182643
Device Name: IRIS 1.0 System
Manufacturer: Crystal Ong
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 09/24/2018
Decision Date: 02/22/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: IRIS 1.0 System
Manufacturer: Crystal Ong
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 09/24/2018
Decision Date: 02/22/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details