Subtle Medical vs United Imaging uAI
Deep-learning reconstruction is where the two meet, and the scanner brand splits them. United Imaging's Deep Recon, HYPER DLR, HYPER Focus and HYPER AiR for PET/CT were cleared under the scanner maker, Shanghai United Imaging Healthcare, so they fit a hospital standardizing on United Imaging CT or MR. Subtle Medical describes its software as vendor-neutral and has FDA clearances for SubtleHD-PET (K254013) and SubtleHD-CT (K254120) from May 2026. A PET program or a department running several scanner brands is the Subtle buyer. The company says SubtleHD(MR) runs sequences up to 80% faster and SubtleHD(PET) scans up to 75% faster. United Imaging's uAI line also includes Easy Triage ICH (K242292) for non-contrast head CT and a rib triage tool, which sit outside the reconstruction question.
Radiology · Reviewed November 2, 2026

Subtle Medical
by Subtle Medical
Vendor-neutral deep-learning software that improves MR, PET and CT image quality on faster or lower-dose protocols.

United Imaging uAI
by Shanghai United Imaging Intelligence
Product family: AI line of United Imaging: head CT and rib triage software plus deep-learning reconstruction for its scanners.
When to pick each one
Subtle Medical
- PET programs and mixed scanner brands
- Calls its software vendor-neutral
- SubtleHD-PET and SubtleHD-CT cleared May 2026
United Imaging uAI
- Hospitals standardizing on United Imaging CT or MR
- HYPER AiR reconstruction for PET/CT
- Head CT triage cleared September 2024
Score
Each row shows points earned of points available under the published rubric.
Subtle Medical
37of 100
United Imaging uAI
35of 100
| Dimension | Subtle Medical | United Imaging uAI | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 7.3 / 18.2 | 0 / 18.2 | +7.3 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 3 / 12 | 8.4 / 12 | -5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Subtle Medical
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Billing period, trial and refund not stated. |
United Imaging uAI
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Sold with United Imaging scanners and workstations. |
Evidence
Subtle Medical
FDA decisions
K254120 (opens in new tab)510(k)2026-05-15
SubtleHD-CT 1.x
K254013 (opens in new tab)510(k)2026-05-14
SubtleHD-PET 1.x
K243250 (opens in new tab)510(k)2025-02-12
SubtleHD 1.x
K240290 (opens in new tab)510(k)2024-08-21
AiMIFY 1.x
K241329 (opens in new tab)510(k)2024-07-11
SubtleSYNTH 1.x
Show 6 more
K233699 (opens in new tab)510(k)2024-04-29
SubtleREFORMAT 1.x
K223623 (opens in new tab)510(k)2023-05-11
SubtleMR 2.3.x
K211964 (opens in new tab)510(k)2021-09-28
SubtlePET
K203182 (opens in new tab)510(k)2021-02-26
SubtleMR
K191688 (opens in new tab)510(k)2019-09-16
SubtleMR
K182336 (opens in new tab)510(k)2018-11-30
SubtlePET
Peer-reviewed
1 PubMed record names Subtle Medical.
United Imaging uAI
FDA decisions
K242292 (opens in new tab)510(k)2024-09-24
uAI Easy Triage ICH (Shanghai United Imaging Intelligence)
K240411 (opens in new tab)510(k)2024-09-06
uAI Portal (Shanghai United Imaging Intelligence)
K210001 (opens in new tab)510(k)2021-04-30
HYPER AiR (Shanghai United Imaging Healthcare)
K210418 (opens in new tab)510(k)2021-04-09
HYPER Focus (Shanghai United Imaging Healthcare)
K193271 (opens in new tab)510(k)2021-01-15
uAI EasyTriage-Rib (Shanghai United Imaging Intelligence)
Show 2 more
K193210 (opens in new tab)510(k)2020-08-04
HYPER DLR (Shanghai United Imaging Healthcare)
K193073 (opens in new tab)510(k)2020-07-06
Deep Recon (Shanghai United Imaging Healthcare)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Subtle Medical | United Imaging uAI |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | n/a | CN |
Scroll horizontally to see both columns.
Common questions
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