510(k) · Cleared
ClearedSpectralmd Deepview Wound Imaging System 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectralmd, Inc. · DPT Probe, Blood-Flow, Extravascular
Cleared on Aug 17, 2017 as substantially equivalent to K124049 (Spectralmd, Inc., 2013) and 1 other predicate after a 262-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Aug 17, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K905232 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK905232 Moor Laser Blood Flow Monitor MBF3Moor Instruments, Ltd. · 1991
- 5 generations backK980383 Mooorldi Laser Doppler ImagerMoor Instruments, Ltd. · 1998
- 4 generations backK032841 Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd. · 2003
- 3 generations backK063561 Moorldls Laser Doppler Line ScannerMoor Instruments, Ltd. · 2007
- 2 generations backK121429 Aimago Easyldi Microcirculation CameraAimago SA · 2012
- 1 generation backK123216 Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm)…Aimago SA · 2013
- This deviceK163339 Spectralmd Deepview Wound Imaging System 2.0Spectralmd, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K905232 | Moor Laser Blood Flow Monitor MBF3 | Moor Instruments, Ltd. | 1991 | — |
| −5 | K980383 | Mooorldi Laser Doppler Imager | Moor Instruments, Ltd. | 1998 | — |
| −4 | K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IR | Moor Instruments, Ltd. | 2003 | — |
| −3 | K063561 | Moorldls Laser Doppler Line Scanner | Moor Instruments, Ltd. | 2007 | — |
| −2 | K121429 | Aimago Easyldi Microcirculation Camera | Aimago SA | 2012 | — |
| −1 | K123216 | Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy… | Aimago SA | 2013 | — |
| 0 (this device) | K163339 | Spectralmd Deepview Wound Imaging System 2.0 | Spectralmd, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
| 2013 | 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 DPT? 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 DPT device
- #1 K233076 Laser Speckle Imaging System (RFLSI CZW)score 8.6 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K124049 | Deepview Digital Video Physiological Portable Imaging SystemSummary page 4…e Classification Extravascular Blood Flow Probe Name: Reference: 21 CFR §870.2120– Class II Product Code: DPT Predicate Devices: K124049: DeepView Digital Video Physiological Portable Imaging System (Primary) K123216: EasyLDI Microcirculation Camera (Additional Pred… | 2013 |
| * | K123216 | Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand…Summary page 4…rence: 21 CFR §870.2120– Class II Product Code: DPT Predicate Devices: K124049: DeepView Digital Video Physiological Portable Imaging System (Primary) K123216: EasyLDI Microcirculation Camera (Additional Predicate) Device Description: The DeepView System 2.0 is a prescription device that… | 2013 |
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 26 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All DPT devicesDPT Probe, Blood-Flow, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DPT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DPT
201in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPT
22in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPT
52in 2025
MAUDE reports naming product code DPT, 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 | 3 | 55 | 0 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 3 | 108 | 0 | 0 |
| 2014 | 3 | 201 | 0 | 5 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 21 |
| 2024 | 1 | — | 22 | 169 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SpectralMD™ DeepView™ Wound Imaging System 2.0 is an optical imaging device intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery and anesthetics. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery), chronic wounds, decubitus ulcers and diabetic ulcers.
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/K163339 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163339: Spectralmd Deepview Wound Imaging System 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163339
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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