510(k) Report

510(k) · Cleared

Cleared

Wallach Digital Imaging System

K950630510(k) TraditionalCleared Nov 22, 1995282-day reviewClass I21 CFR 892.2010

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

Wallach Surgical Devices, Inc. · LMB Device, Digital Image Storage, Radiological

Cleared on Nov 22, 1995 after a 282-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Nov 22, 1995
Review
282 days
Class
Class I
Product code
LMB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950630 Wallach Digital Imaging SystemWallach Surgical Devices, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK970813 Dims (Digital Imaging and Medical System) CL1-5110/5111Denvu, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K970813Dims (Digital Imaging and Medical System) CL1-5110/5111Denvu, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950630Wallach Digital Imaging SystemWallach Surgical Devices, Inc.1995—
+1K970813Dims (Digital Imaging and Medical System) CL1-5110/5111Denvu, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K950630, 1995–1997Source: FDA 510(k) summaries, read by 510(k) Report · 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.

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  • 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970813Dims (Digital Imaging and Medical System) CL1-5110/5111Denvu, Inc.19970

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?

  • Of its descendants, K970813 (Denvu, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LMB devices

LMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMB

FDA has decided no LMB device since 2007.

Median 510(k) review, days · LMB

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

Recalls per year · LMB

1in 2013

2008: 12009: 52011: 22013: 1
2007high 5 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LMB

7in 2025

2007: 12008: 32009: 32010: 162011: 42012: 42013: 72014: 12016: 212017: 102018: 52019: 102020: 82021: 102023: 102024: 92025: 7
2007high 21 (2016) · low 0 (2015)2025

MAUDE reports naming product code LMB, 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—13
20090—53
20100—016
20110—24
20120—04
20130—17
20140—01
20150—00
20160—021
20170—010
20180—05
20190—010
20200—08
20210—010
20220—00
20230—010
20240—09
20250—07
20260—0—

More from Wallach Surgical Devices, Inc.

27 FDA decisions under this applicant name. See the company

  • K021224Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
  • K020711Wallach Loop ElectrodeWallach Surgical Devices, Inc. · 20021 recall
  • K000768Wallach Quantum 500 Electrosurgical GeneratorWallach Surgical Devices, Inc. · 2000
  • K992736Wallach's Ultimate Reusable, Plastic Vaginal SpeculumWallach Surgical Devices, Inc. · 1999
  • K991669PMS 750 FingerswitchWallach Surgical Devices, Inc. · 1999

Recent decisions in LMB

The LMB category page

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  • K983447Wise (II) Image Management SystemSectra-Imtec AB · 19983 recalls
  • K980243Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)Parameter Developments, Inc. · 1998
  • K973463Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, ArchiveO Tech, Inc. · 1997

https://510kreport.com/device/K950630 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950630: Wallach Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950630

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