APEX 415 ANGER CAMERA— 510(k) K884674

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K884674 for APEX 415 ANGER CAMERA, Substantially Equivalent on 1989-04-17. Applicant: Elscint, Inc.. Device class: 1.

Clearance details

Applicant: Elscint, Inc.
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 1988-11-08
Decision date: 1989-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Elscint, Inc.

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Recalls naming K884674

K-number listed on FDA's recall record

Z-0291-2026 — Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass II·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·20250912

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K884674.

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