510(k) · Cleared
ClearedDigiscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 26, 1989 after a 173-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 26, 1989
- Review
- 173 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK884621 DigiscanSiemens Medical Solutions USA, Inc. · 1989
- Descendant · cites it directly · 4 of its ownK955643 Alara Imaging SystemDenoptix, Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK071682 Crystalview T-Series Computed Radiography System, Models T110 (with…Alara, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK974619 Scanaray/CD-Dent Advanced Computerized X-Ray SystemAfp Imaging Corp. · 1998
- Descendant · 3 generations on · 0 of its ownK102479 Alara T210 Computed Radiography SystemAlara, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK990049 CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models…Digident, Ltd. · 1999
Most influential descendants
Showing 5 of 5 · See all- K955643Alara Imaging SystemDenoptix, Inc. · 1996 · cites it directly4descendants
- K071682Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100…Alara, Inc. · 2007 · 2 generations on1descendant
- K974619Scanaray/CD-Dent Advanced Computerized X-Ray SystemAfp Imaging Corp. · 1998 · 2 generations on1descendant
- K102479Alara T210 Computed Radiography SystemAlara, Inc. · 2011 · 3 generations on0descendants
- K990049CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000Digident, Ltd. · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884621 | Digiscan | Siemens Medical Solutions USA, Inc. | 1989 | — |
| +1 | K955643 | Alara Imaging System | Denoptix, Inc. | 1996 | — |
| +2 | K071682 | Crystalview T-Series Computed Radiography System, Models T110 (with Eraser)… | Alara, Inc. | 2007 | — |
| +2 | K974619 | Scanaray/CD-Dent Advanced Computerized X-Ray System | Afp Imaging Corp. | 1998 | — |
| +3 | K102479 | Alara T210 Computed Radiography System | Alara, Inc. | 2011 | — |
| +2 | K990049 | CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and… | Digident, Ltd. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K955643 | Alara Imaging System | 1996 | 4 |
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, K955643 (Denoptix, Inc., 1996) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
https://510kreport.com/device/K884621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884621: Digiscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884621
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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