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8311 PNT

HANS RUDOLPH, INC. · Model 8311 · UDI-DI 00817136026220

JAX Prescription
8
510(k) clearances
2
Adverse events
1
Recalls
4
Facilities

Description

SMC 462535: CUSTOM PNT 8311B

Recalls

DateFirmReason
2007-01-09Philips Medical Systems (Cleveland) IncWhen the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.