HT-RES RTP SYSTEM— 510(k) K894706

Substantially Equivalent

Adac Laboratories

FDA 510(k) clearance K894706 for HT-RES RTP SYSTEM, Substantially Equivalent on 1989-10-11. Applicant: Adac Laboratories.

Clearance details

Applicant: Adac Laboratories
Product code: Code IYE
Advisory panel: Radiology
Date received: 1989-07-24
Decision date: 1989-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.