510(k) Report

FDA applicant

Pem Technologies

Rockville, MD2 decisions2001–20032 recalls

FDA records 2 decisions for Pem Technologies (Rockville, MD) from 2001 to 2003: 2 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYX (Camera, Scintillation (Gamma)). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Pem Technologies since 2007.

Recalls per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Pem Technologies’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?

  • KPSSystem, Tomography, Computed, Emission1decision
  • IYXCamera, Scintillation (Gamma)1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K032063Pem 2400 Pet ScannerPem Technologies · 20031cites it

What has FDA decided for it lately?

  • K032063Pem 2400 Pet ScannerPem Technologies · 20032 recalls
  • K003775Portable Breast Compression DevicePem Technologies · 2001

All 2 as Pem Technologies →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K032063Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo…Jun 19, 2008
  • K032063PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner…Aug 1, 2007