- No public price. Billing period, trial and refund not stated.
- Not disclosed
- Not disclosed
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Radiology
Subtle Medical
by Subtle Medical
Vendor-neutral deep-learning software that improves MR, PET and CT image quality on faster or lower-dose protocols.
On this page
27/100Niche fit
- Regulatory & Compliance18/28
FDA cleared (11 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength7.3/26
1 peer-reviewed paper
- Vendor & Market3/18
Seed-stage or unfunded
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (11 K-numbers on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers7/18
1 peer-reviewed paper
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
Vendor-neutral deep-learning software that improves MR, PET and CT image quality on faster or lower-dose protocols.
No public price. Billing period, trial and refund not stated.
Bottom line
Subtle Medical sells deep-learning software that cleans up MRI, PET and CT images so scans can run faster or at lower dose. The company holds 11 FDA 510(k) clearances, the most recent two in May 2026. Imaging departments buy it, not individual radiologists, and the price is by quote. It fits a department with scanner queues, several scanner brands or a PET programme that wants shorter acquisitions.
What does Subtle Medical sell?
Subtle describes itself as developing "vendor-neutral software solutions that improve image quality on regular and accelerated image protocols, allowing radiologists to expedite patient care." The company grew out of Stanford. Greg Zaharchuk, MD, PhD, and Enhao Gong, PhD, founded it.
The current products are:
- SubtleHD for MR, PET and CT. For MR, the company claims "up to 80% faster MRI sequences". For PET it claims "up to 75% faster PET scans with any commercial radiotracers". The CT version reduces noise and improves low-contrast detectability.
- SubtleSYNTH and SubtleREFORMAT, which sit alongside SubtleHD in the Subtle-ELITE MRI suite.
- AiMIFY, developed with Bracco Imaging, for contrast-enhanced brain MRI with a lower gadolinium dose.
Subtle also names Bayer as a partner on a clinical trial of SubtleGAD. The company says its software is "deployed on over 1,300 scanners in multiple countries". All speed and dose figures above are Subtle's marketing claims.
What FDA clearances does it hold?
Subtle's About page says "11 FDA Clearances", and the FDA's 510(k) database shows eleven decisions for the company:
- SubtlePET: K182336 (30 November 2018) and K211964 (28 September 2021)
- SubtleMR: K191688 (16 September 2019), K203182 (26 February 2021) and K223623 (11 May 2023)
- SubtleREFORMAT: K233699 (29 April 2024)
- SubtleSYNTH: K241329 (11 July 2024)
- AiMIFY: K240290 (21 August 2024)
- SubtleHD: K243250 (12 February 2025)
- SubtleHD-PET: K254013 (14 May 2026)
- SubtleHD-CT: K254120 (15 May 2026)
The CT product was announced on 10 June 2026, nearly four weeks after its clearance date.
How is it priced and how is the company funded?
Subtle sells enterprise licences by quote only.
On 2 June 2026 the company announced a $33M Series C led by Morgan Stanley Expansion Capital, bringing the total to $86M (its own site says "over $85 million raised to date"). Ohad Arazi became CEO and Gong moved to chief science officer.
What is documented beyond the clearances?
Coverage consists of vendor press and trade news from AuntMinnie and ITN. The site links a "Compliance Center" and calls the software "vendor-neutral" but does not list which scanners and PACS systems it works with.
The verdict
The regulatory record is solid: eleven clearances, two of them from this spring. The clinical-benefit record sits mostly with the company, and no read-time or image-quality data from sites running the software is published on its pages.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | — | — | No public price. Billing period, trial and refund not stated. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
What the literature says
1 peer-reviewed study indexed on PubMed evaluate Subtle Medical in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Performance of a deep learning enhancement method applied to PET images acquired with a reduced acquisition time.
- Ciborowski K, Gramek-Jedwabna A, Gołąb M, et al.· Nucl Med Rev Cent East Eur· 2023
- This study aims to evaluate the performance of a deep learning enhancement method in PET images reconstructed with a shorter acquisition time, and different reconstruction algorithms. The impact of the enhancement on clinical decisions was also assessed. Thirty-seven subjects underwent clinical whole-body [18F]FDG PET/CT exams with an acquisition time of 1.5 min per bed position. PET images were reconstructed with the OSEM algorithm using 66% counts (imitating 1 min/bed acquisition time) and 100% counts (1.5 min/bed). Images reconstructed from 66% counts were subsequently enhanced using the S…
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