510(k) · Cleared
ClearedRaven Dry Printer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterling Diagnostic Imaging, Inc. · LMC Camera, Multi Format, Radiological
Cleared on Nov 10, 1997 as substantially equivalent to K912073 (Polaroid Medical Corp., 1991) and 1 other predicate after a 117-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 10, 1997
- Review
- 117 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912073 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912073 Polaroid Helios Laser ImagerPolaroid Medical Corp. · 1991
- This deviceK972660 Raven Dry PrinterSterling Diagnostic Imaging, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912073 | Polaroid Helios Laser Imager | Polaroid Medical Corp. | 1991 | — |
| 0 (this device) | K972660 | Raven Dry Printer | Sterling Diagnostic Imaging, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 LMC? 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 |
|---|---|---|---|
| * | K912073 | Polaroid Helios Laser ImagerSummary page 1…assification II and are categorized as Multi-Format Cameras, 90LMC. Predicate Device Sterling identifies the predicate devices as the Sterling Lynx LP400 Laser Imager (K912073 August 28, 1991) and the 3M Dry View 8700 Laser Imager. FDA's accession number for the Premarket notification for the predicate d… | 1991 |
| * | K945475 | Fuji Medical Laser Imager FL-IM DSummary page 1…r Imager (K912073 August 28, 1991) and the 3M Dry View 8700 Laser Imager. FDA's accession number for the Premarket notification for the predicate devices are K912073 and K945475 respectively. FDA cleared the marketing of the predicate devices in letters dated August 28, 1991 and March 9, 1995. The primary… | 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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K912073.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMC
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LMC
80in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMC
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMC
2in 2018
MAUDE reports naming product code LMC, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 3 | 80 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 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 Raven is a free standing device used to print diagnostic images on a polyester base for viewing on a standard view box and/or print reports and referral quality images on paper. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
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/K972660 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972660: Raven Dry Printer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972660
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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