510(k) · Cleared
ClearedDigitizer Director (HSC025-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howtek, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on Sep 8, 1997 as substantially equivalent to K952914 (Star Technologies, Inc., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Sep 8, 1997
- Review
- 90 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952914 (1995). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952914 Star Technologies, Inc. Film Image Scan SystemStar Technologies, Inc. · 1995
- This deviceK972191 Digitizer Director (HSC025-01)Howtek, Inc. · 1997
- Descendant · cites it directly · 5 of its ownK980213 DI-2000Lumisys, Inc. · 1998
- Descendant · 2 generations on · 3 of its ownK020243 Laserpro 16Eradlink, Inc. · 2002
- Descendant · 3 generations on · 2 of its ownK052938 CR-PROEradlink, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K980213DI-2000Lumisys, Inc. · 1998 · cites it directly5descendants
- K020243Laserpro 16Eradlink, Inc. · 2002 · 2 generations on3descendants
- K052938CR-PROEradlink, Inc. · 2005 · 3 generations on2descendants
- K142718Radlink GPSRadlink, Inc. · 2014 · 3 generations on1descendant
- K242161Radlink GPS Pro ImagingRadlink, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952914 | Star Technologies, Inc. Film Image Scan System | Star Technologies, Inc. | 1995 | — |
| 0 (this device) | K972191 | Digitizer Director (HSC025-01) | Howtek, Inc. | 1997 | — |
| +1 | K980213 | DI-2000 | Lumisys, Inc. | 1998 | — |
| +2 | K020243 | Laserpro 16 | Eradlink, Inc. | 2002 | — |
| +3 | K052938 | CR-PRO | Eradlink, Inc. | 2005 | — |
| +3 | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +4 | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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 LMD? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952914 | Star Technologies, Inc. Film Image Scan SystemSummary page 1…eg Devices: 1.7 Description of Device: DIGITIZER DIRECTOR PACS Class Il Teleradiology Device PAC Peripheral Device Star Technologies FISS (Film Image Scan System) #K952914 Manufactured by Star Technologies, Inc. 515 Shaw Rd Sterling, VA 20166 DIGITIZER DIRECTOR is a DICOM 3.0 compliant secondary im… | 1995 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980213 | DI-2000 | 1998 | 5 |
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.
- Of its descendants, K980213 (Lumisys, Inc., 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LMD devicesLMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMD
FDA has decided no LMD device since 2007.
Median 510(k) review, days · LMD
Too few LMD 510(k)s in any year since 2007 to give a median.
Recalls per year · LMD
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 2025
MAUDE reports naming product code LMD, 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 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DIGITIZER DIRECTOR is a DICOM compatible software package which enables any medical facility personal computer (PC) with adequate memory and the appropriate film digitizer to perform secondary image capture of films using the Howtek film digitizer family. DIGITIZER DIRECTOR does not have any image compression capability. DIGITIZER DIRECTOR is an integrated DICOM network product which translates the images from proprietary digitizer format to DICOM format and sends them on to another DICOM application.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972191: Digitizer Director (HSC025-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972191
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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