510(k) Report

510(k) · Cleared

Cleared

Micro-Focus 50 Cabinet X-Ray

K852634510(k) TraditionalCleared Jul 19, 198529-day reviewClass II21 CFR 892.1680

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

Micro-Focus Imaging., Inc. · MWP Cabinet, X-Ray System

Cleared on Jul 19, 1985 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Jul 19, 1985
Review
29 days
Class
Class II
Product code
MWP
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2012: 1 descendant cleared2017: 1 descendant cleared2019: 2 descendants cleared2018: 1 descendant cleared1990200020102020
  1. This deviceK852634 Micro-Focus 50 Cabinet X-RayMicro-Focus Imaging., Inc. · 1985
  2. Descendant · cites it directly · 5 of its ownK072557 Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp. · 2007
  3. Descendant · 2 generations on · 4 of its ownK122428 Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012
  4. Descendant · 3 generations on · 2 of its ownK170786 Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017
  5. Descendant · 4 generations on · 1 of its ownK173309 Faxitron VisionCTFaxitron Bioptics, LLC · 2018
  6. Descendant · 5 generations on · 0 of its ownK192939 Volumetric Specimen ImagerClarix Imaging · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12012: 12017: 12018: 12019: 2
2007high 2 (2019) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all
  • K072557Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp. · 2007 · cites it directly5descendants
  • K122428Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012 · 2 generations on4descendants
  • K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017 · 3 generations on2descendants
  • K173309Faxitron VisionCTFaxitron Bioptics, LLC · 2018 · 4 generations on1descendant
  • K192939Volumetric Specimen ImagerClarix Imaging · 2019 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852634Micro-Focus 50 Cabinet X-RayMicro-Focus Imaging., Inc.1985—
+1K072557Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp.2007—
+2K122428Faxitron Specien Radiography SystemFaxitron Bioptics, LLC2012—
+3K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC2017—
+4K173309Faxitron VisionCTFaxitron Bioptics, LLC2018—
+5K192939Volumetric Specimen ImagerClarix Imaging2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201210
201710
201810
201920
FIG. 1 — Lineage of K852634, 1985–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MWP device

  1. #1 K202713 TrueView 100 Proscore 7.9 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (6)

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

NumberDeviceApplicantDecidedDescendants
K072557Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp.20075

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, K072557 (Faxitron X-Ray Corp., 2007) has gone furthest, with 5 descendants of its own.

How does its category compare?

All MWP devices

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

FDA decisions per year · MWP

2in 2023

2007: 22008: 12009: 12010: 12011: 12012: 12016: 12017: 12018: 12019: 52020: 22021: 42023: 2
2007high 5 (2019) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWP

154in 2021

2019: 104 days median2021: 154 days median
2007high 154 (2021) · low 104 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MWP

No recall names MWP since 2007.

Adverse event reports per year · MWP

1in 2025

2018: 12021: 32022: 12023: 32024: 12025: 1
2007high 3 (2021) · low 0 (2007)2025

MAUDE reports naming product code MWP, 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
20072—00
20081—00
20091—00
20101—00
20111—00
20121—00
20130—00
20140—00
20150—00
20161—00
20171—00
20181—01
2019510400
20202—00
2021415403
20220—01
20232—03
20240—01
20250—01
20260—0—
Cite this page

510(k) Report. “K852634: Micro-Focus 50 Cabinet X-Ray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K852634

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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