Spectrawave, Inc. (manufacturer, Bedford, MA): 17 new FDA device listings, incl. system, image processing, radiological
Spectrawave, Inc. (Bedford, Massachusetts): 17 new FDA device listings, incl. system, image processing, radiological. Its amount of 17 is top-decile (96th percentile of 2,570 records). Dated 141 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 17 · 96th percentile of 2,570 DeviceEstablishmentPulse records · 17.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 69 related MA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Spectrawave, Inc. |
| Owner / operator | Philips Medical Systems International BV |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Bedford, MA, US |
| New listings | 17 |
| Devices | System, Image Processing, Radiological; X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device; System, Imaging, Optical Coherence Tomography (Oct); System, Imaging, Pulsed Echo, Ultrasonic; Catheter, Intravascular, Plaque Morphology Evaluation; Optical Coherence Tomography, Intravascular Catheter |
| Product codes | LLZ, QHA, NQQ, IYO, OGZ, ORD |
| Device classes | Class II |
| Medical specialties | Radiology, Cardiovascular |
| Brand names | X1-FFR; HyperVue Software; HyperVue Imaging System; Starlight Imaging Catheter; HyperVue Imaging System - Integrated |
| First new listing | 2026-06-16 |
| Latest new listing | 2026-06-16 |
| FDA registration number | 3017654247 |
| Registration expires | 2026-12-31 |
| amount percentile | 96th of 2,570 (median 1, 17.0x median) |
| Peer records CSV (70 MA records) | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-06-16
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (MA first): Philips North America LLC (other, Cambridge, MA) · Performance Fibers OEM LLC (contract manufacturer, Mansfield · Millstone Medical Outsourcing LLC. (contract manufacturer, F · Isomedix Operations Inc. (contract sterilizer, Northborough, · Draeger Medical Systems, Inc. (manufacturer, Andover, MA) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Spectrawave, Inc. and 70 Massachusetts peers
- Massachusetts DeviceEstablishmentPulse records like this one: 70
- Spectrawave, Inc.'s amount: 96th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $14,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Spectrawave, Inc. in Bedford, Massachusetts?
Spectrawave, Inc. (Bedford, MA), a manufacturer, added 17 FDA device listings on 2026-06-16.
How does Spectrawave, Inc. compare to other Massachusetts DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 17 is 17.0x the median of 1 across 2,570 records. It is 141 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Spectrawave, Inc. vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Spectrawave, Inc. | Bedford, MA | 17 | 96th | 2026-06-16 |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA | 6 | 88th | 2026-10-16 |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 |
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.