510(k) Report

FDA applicant

Panoramic Corp.

Ft. Wayne, IN7 decisions1987–20163 recalls

FDA records 7 decisions for Panoramic Corp. (Ft. Wayne, IN) from 1987 to 2016: 7 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 4 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.

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

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

How often FDA has decided Panoramic Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12014: 12016: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2015: 12016: 12017: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Panoramic 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?

  • EHDUnit, X-Ray, Extraoral With Timer3decisions
  • MUHSystem, X-Ray, Extraoral Source, Digital2decisions
  • OASX-Ray, Tomography, Computed, Dental1decision
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K043557Model PC-1000 Panoramic/Cephalometric X-Ray SystemsPanoramic Corp. · 20051cites it
  • K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 20161cites it
  • K882436LASER - 1000Panoramic Corp. · 19881cites it
  • K110371Encompass HF100- Eagle Panoramic/Cephalometric X-RayPanoramic Corp. · 20111cites it
  • K943532Panoramic Corporation HDLXPanoramic Corp. · 19941cites it

What has FDA decided for it lately?

  • K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016
  • K141130EncompassPanoramic Corp. · 2014
  • K110371Encompass HF100- Eagle Panoramic/Cephalometric X-RayPanoramic Corp. · 2011
  • K043557Model PC-1000 Panoramic/Cephalometric X-Ray SystemsPanoramic Corp. · 2005
  • K943532Panoramic Corporation HDLXPanoramic Corp. · 1994
  • K882436LASER - 1000Panoramic Corp. · 19883 recalls
  • K870236Panoramic X-Ray Model PC-1000Panoramic Corp. · 19873 recalls

All 7 as Panoramic Corp. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K870236PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3Jul 14, 2017Class II
  • K870236Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000…Aug 19, 2016Class II
  • K870236Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray…Jun 4, 2015Class II