510(k) · Cleared
ClearedLevel 356 X-Ray Film Processor, Models MD & MD-D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fischer Industries, Inc. · IXW Processor, Radiographic-Film, Automatic
Cleared on Sep 30, 2002 as substantially equivalent to K940112 (Fischer Industries, Inc., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 30, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- IXW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940112 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK940112 X-Ray Film ProcessorFischer Industries, Inc. · 1995
- This deviceK022154 Level 356 X-Ray Film Processor, Models MD & MD-DFischer Industries, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940112 | X-Ray Film Processor | Fischer Industries, Inc. | 1995 | — |
| 0 (this device) | K022154 | Level 356 X-Ray Film Processor, Models MD & MD-D | Fischer Industries, Inc. | 2002 | — |
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 IXW? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940112 | X-Ray Film ProcessorSummary page 1…essor Classification Name: Automatic Radiographic Film Processor Substantial Equivalence: Futura System 30 DX K940112 4/11/95 Description of Device: Automatic Radiographic Film Processor Intended Use:… | 1995 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All IXW devicesIXW Processor, Radiographic-Film, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXW
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · IXW
Too few IXW 510(k)s in any year since 2007 to give a median.
Recalls per year · IXW
No recall names IXW since 2007.
Adverse event reports per year · IXW
2in 2018
MAUDE reports naming product code IXW, 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 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Level 356 X-Ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to develope, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes. This is the sole purpose of this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022154: Level 356 X-Ray Film Processor, Models MD & MD-D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026