PFIZER PZ-CT SCANNER— 510(k) K801446

Name: FDA 510(k) clearance K801446
Creator: U.S. Food and Drug Administration
Published: 1980-07-28

Substantially Equivalent

Pfizer Medical Systems, Inc.

FDA 510(k) clearance K801446 for PFIZER PZ-CT SCANNER, Substantially Equivalent on 1980-07-28. Applicant: Pfizer Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pfizer Medical Systems, Inc.
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 1980-06-20
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAK

view all

K253836 — FCT iStream Phase 22026-09-04
K253450 — BodyTom Elite (NL4000)2026-07-28
K253770 — CardIQ Suite2026-07-21
K253560 — Enhanced Boundary for PCCT2026-06-24
K253026 — Respiratory Gating for Scanners (2.1)2026-06-04

More clearances from Pfizer Medical Systems, Inc.

view all

K803032 — PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.1981-01-22
K802528 — PFIZONIC 150 ULTRASOUND SCANNER1980-12-18
K802529 — PFIZONIC 100 ULTRASOUND SCANNER1980-12-18
K802530 — PFIZONIC 250 ULTRASOUND SCANNER1980-12-18
K802531 — PFIZONIC 200 ULTRASOUND SCANNER1980-12-18

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.