510(k) Report

510(k) · Cleared

Cleared

MD-1835

K964806510(k) TraditionalCleared Mar 4, 199795-day reviewClass II21 CFR 892.1670

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fischer Imaging Corp. · IXL Device, Spot-Film

Cleared on Mar 4, 1997 after a 95-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 4, 1997
Review
95 days
Class
Class II
Product code
IXL
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K964806Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IXL? 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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 IXL devices

IXL Device, Spot-Film: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXL

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXL

Too few IXL 510(k)s in any year since 2007 to give a median.

Recalls per year · IXL

2in 2010

2008: 12010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IXL

1in 2025

2007: 12008: 12010: 42011: 12012: 12024: 22025: 1
2007high 4 (2010) · low 0 (2009)2025

MAUDE reports naming product code IXL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—11
20090—00
20100—24
20111—01
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—02
20250—01
20260—0—

More from Fischer Imaging Corp.

69 FDA decisions under this applicant name. See the company

  • K042095MammotestFischer Imaging Corp. · 20041 recall
  • K021113MammopathFischer Imaging Corp. · 2002
  • K981414LC PositionerFischer Imaging Corp. · 1998
  • K973400Mammotest Adapter DriverFischer Imaging Corp. · 1997
  • K961207EP-X BiplaneFischer Imaging Corp. · 19963 recalls

Recent decisions in IXL

The IXL category page

  • K111304Optima XR120Ge Medical Systems, LLC · 2011
  • K950317Advantx 1824 Spotfilm DeviceGE Medical Systems · 1995
  • K940386Kodak Automixer Iii Integrated, Kodak Automixer Iii 180 LPEastman Kodak Company · 1994
  • K942367Axt 1400 Spotfilm DeviceApplied X-Ray Technologies, Inc. · 1994
  • K924593Diagnost 76 Family*R/F Systems - Release 4.4Philips Medical Systems, Inc. · 19921 recall

https://510kreport.com/device/K964806 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964806: MD-1835.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964806

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026