510(k) · Cleared
ClearedMedi-6000 Medical Image Digitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microtek International, Inc. · LMA Digitizer, Image, Radiological
Cleared on Aug 14, 2009 as substantially equivalent to K021949 (Howtek, Inc., 2002) and 1 other predicate after a 105-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Aug 14, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933632 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933632 | Medscan 12 | Vidar Systems Corp. | 1993 | — |
| −1 | K993597 | PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617 | Vidar Systems Corp. | 1999 | — |
| 0 (this device) | K091288 | Medi-6000 Medical Image Digitizer | Microtek International, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021949 | FulcrumSummary page 1…R 892.2030) 7. Device Product Code: LMA 8. Predicate Device: Manufacturer: Howtek Incorporated Device name: Film digitizer Model name: Fulcrum 510(k) No.: K021949 Manufacturer: VIDAR Systems Corporation Device name: X-ray film digitizer Model name: PI1, TeleRADPRO, VXR-12 plus 51… | 2002 |
| * | K993597 | PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617Summary page 1…Fulcrum 510(k) No.: K021949 Manufacturer: VIDAR Systems Corporation Device name: X-ray film digitizer Model name: PI1, TeleRADPRO, VXR-12 plus 510(k) No.: K993597 9. Device Description: The Medi-6000 is a digitizer that can easily transfer x-ray films into a digital format for patients… | 1999 |
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LMA devicesLMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LMA
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LMA
80in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMA
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMA
1in 2013
MAUDE reports naming product code LMA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 80 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medi-6000 consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Medi-6000 is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. This device is not to be used for primary image diagnosis in mammography. The target users of the device are medical professionals or trained staffs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091288: Medi-6000 Medical Image Digitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091288
Report an extraction error
Are you the manufacturer?
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