510(k) Report

510(k) · Cleared

Cleared

Cobrascan CR-1 Filmless

K022810510(k) TraditionalCleared Oct 11, 200249-day reviewClass II21 CFR 892.2030

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

Radiographic Digital Imaging, Inc. · LMA Digitizer, Image, Radiological

Cleared on Oct 11, 2002 as substantially equivalent to K953942 (Radiographic Digital Imaging, Inc., 1995) after a 49-day review. Its family tree reaches back 1 generation to 1995.

Decided
Oct 11, 2002
Review
49 days
Class
Class II
Product code
LMA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K953942 (1995). No later device cites it as a predicate yet.

K953942 · Cobrascan CX-312 · Radiographic Digital Imaging, Inc. · 199519961998200020022004
K953942 · Cobrascan CX-312 · Radiographic Digital Imaging, Inc. · 19950
  1. Root · 1 generation backK953942 Cobrascan CX-312Radiographic Digital Imaging, Inc. · 1995
  2. This deviceK022810 Cobrascan CR-1 FilmlessRadiographic Digital Imaging, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K953942Cobrascan CX-312Radiographic Digital Imaging, Inc.1995—
0 (this device)K022810Cobrascan CR-1 FilmlessRadiographic Digital Imaging, Inc.2002—
FIG. 1 — Lineage of K022810, 1995–2002Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LMA? 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K953942Cobrascan CX-312
Summary page 3
…SE The Cobrascan CR- 1 Filmless is a computed radiography dual technology scanner. It is an enhanced modification of the Cobrascan CX-3 12T (FDA #K953942) CCD x-ray film digitizer. The indications for use of the Cobrascan CR-1 Filmless is: the identification, c…
Radiographic Digital Imaging, Inc.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 LMA devices

LMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMA

3in 2013

2009: 12010: 22013: 3
2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMA

80in 2013

2013: 80 days median
2007high 80 (2013)2026

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

Recalls per year · LMA

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · LMA

1in 2013

2008: 32012: 12013: 1
2007high 3 (2008) · low 0 (2007)2025

MAUDE reports naming product code LMA, 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—03
20091—00
20102—00
20110—00
20120—01
201338001
20140—00
20150—00
20160—00
20170—00
20180—00
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The indications for use of the Cobrascan CR-1 Filmless is: the identification, capture, digitization and processing of diagnostic x-ray images from x-ray film and from phosphor imaging plates.

Indications for use as stated in the FDA 510(k) statement.

More from Radiographic Digital Imaging, Inc.

3 FDA decisions under this applicant name. See the company

  • K002911XSCAN32 Teleradiology SoftwareRadiographic Digital Imaging, Inc. · 2001
  • K953942Cobrascan CX-312Radiographic Digital Imaging, Inc. · 1995

Recent decisions in LMA

The LMA category page

  • K132183Dicom VideoBar Code Computer, Ltd. · 2013
  • K130636Teleradpro Edge; Teleradpro Edge HD-CCDVidar Systems Corp. · 2013
  • K130406Diagnosticpro EdgeVidar Systems Corp. · 2013
  • K102476TeleradproVidar Systems Corp. · 2010
  • K093809Vidar Dental Film DigitizerVidar Systems Corp. · 2010

https://510kreport.com/device/K022810 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022810: Cobrascan CR-1 Filmless.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022810

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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