Home / Companies / Hypermed Imaging, Inc.

Hypermed Imaging, Inc.

FDA Regulatory Profile

Hypermed Imaging, Inc. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Hypermed Imaging, Inc." and its spelling variant "Hypermed Imaging".

Latest inspection: Aug 19, 2019 · NAI
Latest 510(k): Dec 16, 2016

Reviewing Hypermed Imaging, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Hypermed Imaging, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA inspections

1 inspection on Aug 19, 2019.

Date	Site	Product	Classification	FEI
Aug 19, 2019	Greenwich, CT	Devices	No Action Indicated (NAI)	3013406514

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3013406514	Greenwich, CT	1	Aug 19, 2019

Recent 510(k) clearances

1 510(k) clearance on Dec 16, 2016.

K-Number	Device	Date
K161237	HyperView Hyperspectral Tissue Oxygenation Measurement System	Dec 16, 2016

Need more than this page shows? Ask about Hypermed Imaging, Inc. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.