510(k) · Cleared
ClearedDisposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable Microscope Cover (Various):X-Ray Covr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fairmontmedical · IZJ Camera, X-Ray, Fluorographic, Cine Or Spot
Cleared on Oct 9, 1997 after a 125-day review. The FDA summary names no predicate by number.
- Decided
- Oct 9, 1997
- Review
- 125 days
- Class
- Class II
- Product code
- IZJ
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All IZJ devicesIZJ Camera, X-Ray, Fluorographic, Cine Or Spot: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZJ
FDA has decided no IZJ device since 2007.
Median 510(k) review, days · IZJ
Too few IZJ 510(k)s in any year since 2007 to give a median.
Recalls per year · IZJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZJ
1in 2023
MAUDE reports naming product code IZJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machine utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field. The DXC provides a sterile barrier between the patient and the X-ray machine. Contaminants from the operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants…
Read the full statement (133 words)
The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machine utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field.
The DXC provides a sterile barrier between the patient and the X-ray machine. Contaminants from the operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation.
This product is marketed towards surgeons and hospitals concerned with the convenience and protection of covering an operative X-ray machine, so that it will not contaminate the sterile field.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972130: Disposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable Microscope Cover (Various):X-Ray Covr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972130
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026