FDA applicant

Image Stream Medical, Inc.

Littleton, MA2 decisions2008–20100 recalls

FDA records 2 decisions for Image Stream Medical, Inc. (Littleton, MA) from 2008 to 2010: 2 510(k) clearances. All are in product code FTA (Light, Surgical, Accessories). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Image Stream Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Image Stream Medical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Image Stream Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Image”

FDA records each applicant name separately; these may or may not be the same firm.

Image-Guided Neurologics, Inc. 22 Image Analysis, Inc. 10 Image Data Corp. 6 Image Systems, Inc. 3 Image Diagnostics, Inc. 3 Image Diagnost International GmbH 2 Image Instruments GmbH 1 Image of Hawaii 1 Image Premastering Services, Inc. 1 Image Enhancements 1 Image Medical, Inc. 1 Image Technology, Inc. 1

Image Stream Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Image”