MD-5 · Class B manufacturing licence
PinnacleAI® GPT-OS v1.0.0 · Non-diagnostic developmental-support software
What this means for your family
A defined intended use lets your family understand what the software is designed to support and when professional clinical evaluation is needed.
- Licence number
- MFG/MD/2026/000248
- Issuer
- State Licensing Authority · Telangana Drugs Control Administration
- Licence holder
- Bharath Healthcare Laboratories Pvt. Ltd.
- Issued
- 21 April 2026
- Intended population
- Children aged 0–12
- Intended functions
- Developmental ability measurement, readiness tracking, progress forecasting and adaptive therapy-plan support
- Export certificate
- Free Sale Certificate FSC/MD/2026/000741 · 23 September 2026
What this supports
The supplied Form MD-5 licenses the listed Class B device for manufacture for sale or distribution at the specified premises. Intended users include parents, therapists, educators and caregivers supporting children aged 0–12.
Scope & limits
Applies to the named device, version, intended use and premises. It does not establish diagnostic authority, clinical effectiveness or the registration of every centre.
The operative licence reads 000248. A corrected forwarding letter also reads 000248; the older forwarding letter supplied as PinnacleAI®_SAMD_License_CL.pdf also reads 000150. The CL file is a forwarding letter, not a separate classification approval. Use the operative licence and corrected letter together. Free Sale Certificate FSC/MD/2026/000741 was issued on this licence on 23 September 2026; see the FSC record.
Source: Original Form MD-5, page 1 including device annexure; supplied PinnacleAI®_SAMD_License.pdf re-inspected 18 September 2026.
Collection inspected: · Scope rechecked: 19 September 2026 · Current issuer or registry status: not independently confirmed.
The exact source
Section linkThe software is intended to assist parents, therapists, educators, and caregivers by providing developmental ability measurement, readiness tracking, progress forecasting, and adaptive therapy-plan support for children aged 0-12 years.
Open the source-copy page to inspect the quoted wording in context. Existing redactions remain visible.
Source inspection: . Quoted wording compared with the complete public source-copy page. The intended-use statement is for the named non-diagnostic device and age range; the quote does not extend the device indication to all ages.
Record revision history
- — Added visually checked source excerpt, exact PDF page link and source-copy preview.
Cite this evidence summary
This citation identifies Pinnacle’s evidence summary. Follow the original-source links when citing the underlying document.
This page summarizes the listed evidence; it is not an issuer’s verification service. A source review is separate from checking current issuer status.