NewTom 7G— 510(k) K220664

Name: FDA 510(k) clearance K220664
Creator: U.S. Food and Drug Administration
Published: 2022-05-06

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K220664 for NewTom 7G, Substantially Equivalent on 2022-05-06. Applicant: Cefla S.C.. Device class: 2.

Clearance details

Applicant: Cefla S.C.
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2022-03-07
Decision date: 2022-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAK

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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
K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.02026-05-20

More clearances from Cefla S.C.

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K260716 — Neowise2026-05-04
K252353 — myray ProXIma X62026-03-10
K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,2024-04-01
K231990 — Apex Locator2024-02-13
K223794 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS2023-01-17

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.