510(k) Report

FDA applicant

Usa Instruments, Inc.

Aurora, OH64 decisions1997–20058 recalls

FDA records 64 decisions for Usa Instruments, Inc. (Aurora, OH) from 1997 to 2005: 64 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 93 predicates, 60 of them its own earlier devices. 8 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 Usa Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Usa Instruments, Inc. since 2007.

Recalls per year

4in 2007

2007: 4
2007high 4 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Usa Instruments, 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?

  • MOSCoil, Magnetic Resonance, Specialty63decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

Whose devices does it build on?

Its devices cite 93 predicates; 60 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 89 times; 60 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.

  • K980157Premier 7000 CTL Spine CoilUsa Instruments, Inc. · 19988cite it
  • K001209Insight Plus 9000 Phased Array Torso and Pelvis CoilUsa Instruments, Inc. · 20007cite it
  • K001870Millennium 9000 Phased Array Neurovascular CoilUsa Instruments, Inc. · 20007cite it
  • K021330Magnetom Trio Quadrature TX/RX Head CoilUsa Instruments, Inc. · 20024cite it
  • K972205Alpha 7000 Quadrature Wrist CoilUsa Instruments, Inc. · 19974cite it
  • K994345Magna 5000 Phased Array CTL Spine CoilUsa Instruments, Inc. · 20004cite it

What has FDA decided for it lately?

  • K052916Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 20051 recall
  • K0526211.5T 16 Channel Brain-Spine Array CoilUsa Instruments, Inc. · 20051 recall
  • K0525841.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005
  • K0525853T HD Breast ArrayUsa Instruments, Inc. · 20055 recalls
  • K050728Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc. · 2005
  • K042342Millennium Iii 3T-8-Channel Neurovascular CoilUsa Instruments, Inc. · 2004
  • K04220711000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004
  • K0421863.0T 8-Channel CTL Spine ArrayUsa Instruments, Inc. · 2004

All 64 as Usa Instruments, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K041695The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is…Jan 31, 2007
  • K041695The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is…Jan 31, 2007
  • K041695The recalled product is the medial biopsy plate, part #2414342. The biopsy plate is…Jan 31, 2007
  • K041695The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate…Jan 31, 2007
  • K041695LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral…Nov 21, 2006
  • K0526211.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System.Sep 20, 2006