510(k) Report

510(k) · Cleared

Cleared

Amsis RDS, Radiographic Discography Kit

K903808510(k) TraditionalCleared Jan 22, 1991155-day reviewClass II21 CFR 892.1730

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

Advanced Med/Surg, Inc. · IZG System, X-Ray, Photofluorographic

Cleared on Jan 22, 1991 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 22, 1991
Review
155 days
Class
Class II
Product code
IZG
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K903808Source: 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 IZG? 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 has not posted a summary or statement for it, 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 IZG devices

IZG System, X-Ray, Photofluorographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZG

FDA has decided no IZG device since 2007.

Median 510(k) review, days · IZG

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

Recalls per year · IZG

No recall names IZG since 2007.

Adverse event reports per year · IZG

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code IZG, 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—00
20080—01
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Advanced Med/Surg, Inc.

10 FDA decisions under this applicant name. See the company

  • K942108Cohort Bone BrushAdvanced Med/Surg, Inc. · 1994
  • K931538Amset (TM) Cannulated Bone ScrewAdvanced Med/Surg, Inc. · 1994
  • K921645Amsen Spine Impactor InstrumentsAdvanced Med/Surg, Inc. · 1992
  • K921643Amsen Posterior Disc EvacuatorAdvanced Med/Surg, Inc. · 1992
  • K921644Amsen Hockey Stick ChiselAdvanced Med/Surg, Inc. · 1992

Recent decisions in IZG

The IZG category page

  • K960082Discography KitSpinal Specialties, Inc. · 1996
  • K960146G.E. Sterile Disposable Radiographic Contrast TrayGE Medical Systems · 1996
  • K913436Pxi Pneumatic Compression PaddleBrotherston/Pxi · 1992
  • K920393MU125M Mobile X-Ray SystemShimadzu Medical Systems · 1992
  • K910503Discography KitB. Braun of America, Inc. · 1991

https://510kreport.com/device/K903808 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903808: Amsis RDS, Radiographic Discography Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903808

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