510(k) Report

FDA applicant

Analogic Corp.

Peabody, MA39 decisions1981–20213 recalls

FDA records 39 decisions for Analogic Corp. (Peabody, MA) from 1981 to 2021: 39 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 34 predicates, 18 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Analogic Corporation”.

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 Analogic Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 22014: 12016: 12018: 22021: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • JAKSystem, X-Ray, Tomography, Computed7decisions
  • KPRSystem, X-Ray, Stationary6decisions
  • HGMSystem, Monitoring, Perinatal5decisions
  • DPSElectrocardiograph3decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)3decisions
  • DSIDetector And Alarm, Arrhythmia3decisions

Also: LLZ (2), IYO (2), DXH (1), LMD (1), MWI (1), MQB (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 128 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 114 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 34 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 18 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.

  • K962424NPB-4000Analogic Corp. · 19963cite it
  • K002503Fetalgard LiteAnalogic Corp. · 20003cite it
  • K030931C3 Patient MonitorAnalogic Corp. · 20033cite it
  • K041434C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 20043cite it
  • K964890Anatom 2000Analogic Corp. · 19972cite it
  • K140126Sonic WindowAnalogic Corporation · 20142cite it

What has FDA decided for it lately?

  • K201231CTxx85 CT ScannerAnalogic Corporation · 2021
  • K182147CTXX85Analogic Corporation · 2018
  • K172058CT6485, CT12885Analogic Corporation · 2018
  • K161342Sonic WindowAnalogic Corporation · 2016
  • K140126Sonic WindowAnalogic Corporation · 2014
  • K071430Synerad Omni, Models AN6255 and AN6265Analogic Corp. · 2007
  • K070829Synepix 4600 DetectorAnalogic Corporation · 2007
  • K051903Fetalgard Lite-Nibp, Model FGL-NibpAnalogic Corporation · 2005

All 32 as Analogic Corp. →All 7 as Analogic Corporation →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K001341KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system.…Oct 20, 2005
  • K040995Analogic SyneRad Multi Digital Radiology System, Model AN6150Oct 14, 2005
  • K001341Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The…Feb 20, 2004