510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K827346Substantially Equivalent

Spiraflow 2001, Multi-Directional Tomographic Unit

Rayflow Italia S.r.l., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827346 is the FDA 510(k) clearance record for SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT, cleared for Rayflow Italia S.R.L. on . FDA records list one 510(k) clearance for Rayflow Italia S.R.L. As of , FDA records show no recalls naming K827346.

Clearance record

Decision date
Received
(54 days to decision)
Review panel
Unknown
Applicant
Rayflow Italia S.R.L. 4221 Richmond Rd., NW, Walker MI
Third party review
No