510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230691Substantially Equivalent

HyperVue™ Imaging System

Spectrawave, Inc., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230691 is the FDA 510(k) clearance record for HyperVue™ Imaging System, a class II device, cleared for Spectrawave, Inc. on under FDA product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)). FDA's definition for product code NQQ reads: "This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging". FDA records list 6 510(k) clearances for Spectrawave, Inc., from to . As of , FDA records show no recalls naming K230691.

Clearance record

Decision date
Received
(86 days to decision)
Product code
NQQ System, Imaging, Optical Coherence Tomography (Oct)
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Spectrawave, Inc. 12 Oak Park Dr., Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQQ

Trailing 12 months
3 clearances under product code NQQ in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NQQ, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260