510(k) Report

FDA applicant

Adac Laboratories

Milpitas, CA88 decisions1978–200673 recalls

FDA records 88 decisions for Adac Laboratories (Milpitas, CA) from 1978 to 2006: 88 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and LLZ (System, Image Processing, Radiological). Its devices cite 42 predicates, 30 of them its own earlier devices. 73 recalls are linked to its devices, 6 Class I.

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 Adac Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Adac Laboratories since 2007.

Recalls per year

1in 2025

2007: 22009: 22010: 52011: 212012: 32013: 22014: 42015: 102016: 12017: 122019: 5, 5 Class I2020: 12023: 2, 1 Class I2025: 1
2007high 21 (2011) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Adac Laboratories’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?

  • KPSSystem, Tomography, Computed, Emission35decisions
  • LLZSystem, Image Processing, Radiological14decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified7decisions
  • IYXCamera, Scintillation (Gamma)6decisions
  • IYEAccelerator, Linear, Medical6decisions
  • MUJSystem, Planning, Radiation Therapy Treatment3decisions

Also: JWM (2), JAD (2), JAK (1), IZI (1), LMB (1), LNH (1).

Whose devices does it build on?

Its devices cite 42 predicates; 30 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 92 times; 30 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.

  • K951581PINNACLE3 ApexAdac Laboratories · 19965cite it
  • K993946Pegasys UltraAdac Laboratories · 20005cite it
  • K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 20005cite it
  • K002237P3IMRT TMAdac Laboratories · 20015cite it
  • K971878Vantage 2.1 ExspectAdac Laboratories · 19974cite it
  • K041182SyntegraAdac Laboratories · 20044cite it

What has FDA decided for it lately?

  • K062298Apollo Gamma Camera SystemAdac Laboratories · 20061 Class I recall
  • K061029Jetstream WorkspaceAdac Laboratories · 20061 recall
  • K060020Autoquant PlusAdac Laboratories · 2006
  • K051351Precedence Spect/CT Imaging SystemAdac Laboratories · 20051 recall
  • K042880Jetstream WorkspaceAdac Laboratories · 20041 recall
  • K042903AutospecsAdac Laboratories · 2004
  • K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 20047 recalls
  • K041218Griffin Spect/CT Imaging SystemAdac Laboratories · 200411 recalls

All 88 as Adac Laboratories →

What has been recalled?

73 recalls linked to its devices; the latest:

  • K041577Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5…Aug 5, 2025Class II
  • K062298BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format…Dec 15, 2023Class I
  • K062298BrightView, Gamma Camera System, Product Code 882480.Nov 30, 2023Class II
  • K042880Emission Computed Tomography System Image Process System - Product Usage: intended for…Nov 19, 2020Class II
  • K982911Forte Gamma Camera System is intended to produce images depicting the anatomical…Sep 19, 2019Class I
  • K033254Forte Gamma Camera System is intended to produce images depicting the anatomical…Sep 19, 2019Class I