510(k) Report

FDA applicant

Sicel Technologies, Inc.

Morrisville, NC7 decisions2004–20080 recalls

FDA records 7 decisions for Sicel Technologies, Inc. (Morrisville, NC) from 2004 to 2008: 7 510(k) clearances. Most are in product codes LHN (System, Radiation Therapy, Charged-Particle…) and NZT (Dosimeter, Ionizing Radiation, Implanted). Its devices cite 22 predicates, 12 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sicel Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2008

2007: 12008: 3
2007high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sicel Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sicel Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LHNSystem, Radiation Therapy, Charged-Particle, Medical3decisions
  • NZTDosimeter, Ionizing Radiation, Implanted2decisions
  • IYEAccelerator, Linear, Medical2decisions

Whose devices does it build on?

Its devices cite 22 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 12 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K052118Dose Verification SystemSicel Technologies, Inc. · 20064cite it
  • K061051Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool, DVS-D-a, DVS DosimeterSicel Technologies, Inc. · 20063cite it
  • K040687Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 20042cite it
  • K071399Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool, DVS-D-a: DVS…Sicel Technologies, Inc. · 20072cite it
  • K083035Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 20081cites it
  • K080004Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 20081cites it

What has FDA decided for it lately?

  • K083035Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
  • K081859Modification to Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2008
  • K080004Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
  • K071399Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool, DVS-D-a: DVS…Sicel Technologies, Inc. · 2007
  • K061051Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool, DVS-D-a, DVS DosimeterSicel Technologies, Inc. · 2006
  • K052118Dose Verification SystemSicel Technologies, Inc. · 2006
  • K040687Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004

All 7 as Sicel Technologies, Inc. →